Macular Degeneration Treatments and Experiments

Available Macular Degeneration Treatment

2011-01-28T05:56:00.000-08:00

The macular is the central part of the retina and is the area where the fine detail of sight is formed so it is very important. Sometimes the macular degenerates blurred vision occurs. This is often the first sign that something is wrong with the eye. Distorted vision is also a symptom and if either of these conditions occur you should visit your nearest doctor as soon as possible. The condition can be treated, but like all illnesses, the quicker it can be caught the better. If left completely untreated macular degeneration can lead to blindness.

It isn't completely accurate to refer to just one condition known as macular degeneration. In fact there is dry age related macular degeneration, and wet age related macular degeneration. Dry AMD develops very slowly and is caused by the light sensitive cells breaking down as described above. Wet AMD is much rarer and is more serious too as it is more likely to lead to complete blindness if not treated.

This occurs when the blood vessels in the eye begin to grow at an abnormal rate. This growth forces the retina away from the eye wall and this detachment is extremely serious and will eventually lead to blindness. The signs of wet AMD are seeing straight lines as slightly curved and medical attention is vital immediately.

There are treatments available for both these conditions. Dry AMD is the much less serious condition of the two, and even making a few lifestyle changes can go some way to keeping the condition from worsening. Dry AMD occurs through the aging of the eye, so you can slow this down considerably by making your eyes more healthy and strong. This can be done through making healthy lifestyle changes and carrying out special eye exercises too. The condition can be slowed right down with simple changes to your everyday life such as these. Eating plenty of vegetables that are rich in vitamins and minerals is vital too.

If the condition is in the early stages then the eye doctor may well prescribe a course of injections with an anti-vascular endothelial growth drug. If the condition is too advanced or if these drugs do not help the problem then laser treatment may be able to stop the progression of the problem, although it cannot return vision that has been lost.

Eye surgery is quick and painless and the recovery period is short. That makes it a viable option for many people. Whilst the cost of such a treatment was extremely high many years ago, today the price is much more affordable. Because it is able to halt the growth of problems, it is extremely popular and has helped thousands of people across the UK. Regular check ups are absolutely vital if you want to catch any problems such as this early on.

There is a selection of macular degeneration treatment available and your eye doctor will prescribe that which is the most appropriate. Laser vision correction surgery is an effective way to restore sight and prevent the condition from worsening. Laser eye surgery can be used to treat other conditions too for example it is highly effective in cataracts surgery.

Stargardt Macular Degeneration

2011-01-23T10:41:00.000-08:00

By: Macular Degeneration In General

One of the more popular juvenile macular degeneration is the Stargardt Macular Degeneration. This category of macular degenerationi was first reported in 1901 by a German ophthalmologist, Karl Stargardt. It has the common feature of loss of central vision. In 1963, France ophthalmologist Adolphe Fransceschetti used the term Fundus flavimaculatus for a degenerative loss of central vision, but soon to be identified as Stargardt Macular Degeneration by Hadden and Gass in 1976.

This macular dystrophy affects about one in every 10,000 children. The problem may start anytime between the ages 6 and 20, but patients may not notice until they reach their 30s or 40s. First, the children may experience difficulty in reading, and complaining of some blind spots that are often gray, black or hazy at their central vision. They will need more time to adjust between the different lighting of the room too, between light and dark environments.
The dystrophy affects the retina, that sensitive tissue that lies at the back of the eye, focusing especially in the middle region called the macula. The macula is where focus is, that area that is highly sensitive and strong enough to give us the sharp central vision for tasks such as reading, driving and recognising faces.

Stargardt macular degeneration is similar to dry macular degeneration, with the build-up of abnormal yellow pigment substance called lipofuscin building up in cells underlying the macula. Patients will also experience problem with night vision, and it will be difficult for them to move around in places with low lighting. In some others, the patient may also experience colour impairment at advanced stages of the disease.

Vision loss is usually slow, until the 20/40 level. It may suddenly shoot right up to 20/200 where the patient is considered legally blind and forbidden from driving. In some cases, it may even deteriorate to 10/200 within a matter of months.

Genes are a big issue when it comes to Stargardt macular degeneration. A group of genes collectively known as the ABC genes, was found to be the culprit of this juvenile macular degeneration, a discovery made since 1997. The ABCA4 gene, responsible for the production of protein used as an energy transport to and from photoreceptor cells in the retina, mutates and produces dysfunctional protein that cannot perform such transport function. The useless ABCA4 protein then allows the accumulation of yellow, fatty material to accumulate in the retina, slowly covering the macularand ultimately causes the loss of vision. However, more studies had to be done to further understand how the mutated genes affect the biochemistry of the retina.
All is not lost for patients with Stargardt disease. It was found that patients may slow down the progression of vision loss by wearing UV protective sunglasses and avoid exposure to bright light. Although there is not yet any effective treatment for this form of macular degeneration at this moment, it is believed that the identification of the genes behind macular degeneration will help the search for new strategies and therapies. The latest is a study scheduled to begin in 2011, for the injection of embryonic stem cells into the eyes of twelve patients affected by the disease. The Advanced Cell Technology announced in November 2010 that the FDA had approved this injection and study.

Stargardt Macular Degeneration may be either autosomal or recessive trait type. A person may not have prior family history, but may have a recessive gene. If both parents carry a mutated gene, there is always a chance for the child to develop macular dystrophy. In fact, there may be more than one family member who gets Stargardt. For children who did not develop Stargardt, there is again the possibility of carrying the mutant gene, and pass on to their children instead. The chances will be 25%.
Three tests are used to check the presence of fundus flecks and the loss of cones to determine whether a patient has Stargardt Macular Degeneration. It may be fluorescein angiography, electroretinography or electrooculography. Since this problem is rare, it is not a widely studied subject. The discovery of genetic mutation in Stargardt may have encouraged the findings of genetic links for age-related macular degeneration, but further studies on the age-related macular degeneration may also become the contributing factor towards better understanding of Stargardt’s disease and its possible lead to new treatment. Whichever way it may be, it will always remain hopeful for parents and their affected children.

Can Eye Drops With Pirenoxine Be Used to Treat Cataracts?

2011-01-15T01:14:00.000-08:00

by;Dr. Ari Weitzner

For over 60 years, cataracts has been treated in China with eye drops containing the non-prescription drug pirenoxine.

Researchers recently tested the potential effectiveness of pirenoxine as a treatment for cataracts by investigating whether and how pirenoxine interacts with selenite or calcium ions, which have been proven as factors leading to the formation of lens cataracts.

As reported in the journal Inorganic Chemistry, researchers found that pirenoxine reduced the cloudiness of the lens solution containing calcium by 38 per cent and reduced the cloudiness of the selenite solution by 11 per cent.

Researchers concluded that the results may provide a rationale for using pirenoxine as an anti-cataract agent and advocated further biological studies.

Novartis gains new indication for Lucentis in EU for vision loss due to Diabetic Macular Edema

2011-01-09T01:28:00.000-08:00

By:Financial

The European Commission has granted Novartis a new indication for Lucentis (ranibizumab) to treat patients with visual impairment due to diabetic macular edema (DME), a leading cause of blindness in the working-age population in most developed countries.

Laser therapy, the current standard of care, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME.

"Similarly to wet age related macular degeneration, diabetic macular edema can cause disabling vision loss. While vision loss as a consequence of diabetes affects only a very small proportion of people with the disease, it is one of the most feared complications," said Don Curran, Chair, AMD Alliance International. "Visual impairment impacts everything from managing social interactions to the ability to work - thus, for most people it means a loss of independence."

The approval of Lucentis was based on data from two Novartis-sponsored clinical trials, RESTORE and RESOLVE, which showed that Lucentis was superior in providing rapid and sustained visual acuity gain versus sham (dummy) therapy or laser therapy, the current standard of care.

"In the clinical trials, Lucentis-treated patients began to recover their vision as early as eight days after the first injection on average, and vision improvement was maintained at one year," said Gabriele E. Lang, Professor, University Eye Hospital, University of Ulm, Germany. "The vision improvement for many of these patients was clinically significant, meaning that they regained the ability to carry out day-to-day activities such as driving."

The RESTORE study showed patients treated with Lucentis alone or with Lucentis plus laser therapy gained an average of 6.8 letters and 6.4 letters, respectively, in visual acuity at 12 months compared to baseline, while laser-treated patients gained an average of 0.9 letters as measured on a standard ETDRS eye chart.

The RESOLVE study showed that Lucentis-treated patients gained an average of 10.3 letters in visual acuity at 12 months compared to baseline while sham-treated patients, some of whom also received laser treatment, lost an average of 1.4 letters.

"Since its first launch in the EU in 2007, Lucentis has become the gold standard treatment of wet AMD and its use has stimulated research into other ocular conditions," said David Epstein, Division Head of Novartis Pharmaceuticals. "Our continued investment in the clinical development of Lucentis means that another group of patients who are at risk of losing their eyesight will have the option of a licensed therapy that could help save their vision."

"The pivotal data from RESTORE and RESOLVE studies are further supported by results of an independent US study examining Lucentis for the treatment of DME compared to standard of care. Conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), this study showed that at 12 months patients treated with Lucentis plus laser gained an average of nine letters in visual acuity compared to baseline while patients treated with laser therapy alone gained an average of three to four letters. In addition, the study demonstrated superior gains in visual acuity among Lucentis-treated patients up to two years, with a reduced number of Lucentis injections required the second year compared to the first. Specifically, there was a median of only two to three injections required in the second year of treatment compared to a median of eight to nine injections required in the first year," Novartis said.

Diabetic macular edema (DME) is a consequence of diabetic retinopathy, the most common diabetic eye complication. DME is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries.

Lucentis offers an entirely new pharmacological approach to treatment for visual impairment due to DME compared to the current standard of care, which involves the use of laser burns to stop capillary leakage and reduce swelling. Lucentis is an antibody fragment that is injected into the eye and neutralizes vascular endothelial growth factor (VEGF), a protein that is known to increase vascular permeability, resulting in capillary leakage and macular edema in patients with diabetes.

Lucentis was generally well tolerated in DME clinical studies, either when given as monotherapy or when combined with laser treatment. Its safety profile was consistent with the well established profile in patients with wet age-related macular degeneration (wet AMD). There was an incidence of arterial thromboembolic events (<=3.5%) observed in the DME clinical trials, consistent with what was seen in the wet AMD clinical trials, with no significant difference between the groups treated with Lucentis compared to sham or laser therapy. Ocular adverse events were similar to those seen in the wet AMD trials, with an incidence of 1.4% endophthalmitis in the pooled pivotal studies.

Lucentis is currently licensed in more than 85 countries for the treatment of wet AMD. It receives continuous safety monitoring via a systematic pharmacovigilance system and there is more than 750,000 patient-treatment years of exposure to date for Lucentis.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States, where Lucentis is also approved for the treatment of macular edema following retinal vein occlusion (RVO). In addition, Genentech is conducting two Phase III studies, RISE and RIDE, in patients with diabetic macular edema with results expected in 2011. Novartis has exclusive rights in the rest of the world and has filed in the European Union for approval of Lucentis for the treatment of visual impairment due to macular edema secondary to RVO.

Macular Degeneration Treatments

2011-01-02T16:42:00.000-08:00

by:Akler Eye Center

Macular degeneration, or Age-Related Macular Degeneration (ARMD) is a condition related to aging of the eye that causes loss of the central vision. It is the commonest cause of blindness in Americans over 55 years old. Approximately 10 million people in the United States are affected. Smoking, high blood pressure, family history of ARMD, and poor diet are all risk factors for the development of ARMD.

The macula is the center most part of the retina, and is responsible for the sharp vision that allows us to read and drive. In some people, as the eye ages, deposits develop in the retina (dry ARMD). This can cause the macula to function imperfectly, which leads to blurry vision. Only 10% of patients develop the wet form of ARMD. In this more devastating form, abnormal blood vessels grow in the macula, and when they leak or bleed, severe loss of the central vision often results.

The symptoms of macular degeneration are blurring of the vision, which causes difficulty with reading or driving. Macular degeneration does not cause total blindness because the side vision is not affected.

At Akler Eye Center in Dearborn MI, a complete eye examination including dilation of the pupil will allow Dr. Akler to detect both mild and severe forms of macular degeneration. If ARMD is found, further testing may include a fluorescein angiogram and optical coherence tomography (OCT). Fluorescein angiography involves injecting dye into the arm and photographing it as it circulates in the retina. Abnormal blood vessel growth and leakage may be detected. OCT is a computerized picture of the macula that shows if it is swollen with fluid. Both of these tests are performed onsite.

Treatments for macular degeneration are primarily targeted at keeping the retina as healthy as possible and screening for early signs of the wet form of ARMD. A study performed by the National Eye Institute demonstrated that taking special vitamins for the eye that contain anti-oxidants (A, C, E and beta-carotene with zinc) reduces the risk of developing severe vision loss. A home screening tool known as an Amsler Grid allows the patient to check the vision with one eye at a time. If the grid paper lines are wavy or faded, an eye examination is needed urgently.

If the wet form of ARMD is present, the current treatment involves injection of medication into the eye. The medication is targeted at reducing the growth of abnormal blood vessels in the macula.

Dr. Michelle Akler recommends regular eye examinations to screen for macular degeneration, especially in older patients and those with a family history of ARMD. Early detection and treatment allows for the best visual outcome in this difficult condition.

Treatment For Wet Macular Degeneration in Seniors

2010-12-27T05:25:00.000-08:00

by: Admin
The National Eye Institute (NEI) had published their facts about Age-Related Macular Degeneration (ARMD) to help patients and their family members to search for general information about the disease.

Age Related Wet Macular Degeneration

In its attempt to ensure better public understanding of the disease, it had detailed the ARMD by starting on its definition. The NEI defined ARMD as “a disease associated with aging that gradually destroys sharp, central vision.” It is then explained that central vision is important to see fine details and helps common daily tasks such as reading and driving. It has to be noted that ARMD causes no physical pain to the patients.

There are two types of ARMD, which is the dry and the wet ARMD. In most cases, elderly adults develop the dry ARMD and it is the most common form of the disease, with some of them progressing into wet ARMD when abnormal blood vessels start developing and ruptures within. Wet ARMD can be treated, but not fully cured, by laser surgery, photodynamic therapy and injections into the eye. These treatments may actually just delay the process of being legally blind, but patients need to be aware that conditions will continue to worsen over time.

Treating wet ARMD with Laser surgery is a procedure which utilizes the laser technology to destroy fragile, leaky blood vessels that had formed abnormally. A high energy light beam is directly focused on the new blood vessels, and it destroys them to prevent further loss of vision. The negative side of this treatment is that it potentially destroys other healthy cells surrounding the treatment area.

Only a small percentage of patients may use laser to treat wet ARMD. The procedure is performed at the doctor’s office or an eye clinic, and laser is more effective if the abnormal, leaky blood vessels are developed away from the middle of the macula, which is called the fovea. It does not mean that the abnormal blood vessels will automatically stop developing after laser surgery, in fact repeated treatments are necessary as the risk of developing new abnormal blood vessels post surgery is high. In some cases, the patient may still suffer vision loss progressively despite repeated treatments.

Another treatment, called the photodynamic therapy, involves the injection of a drug called verteporfin into the patient’s arm, and it travels throughout the body including the new blood vessels in the eye. The drug will attach itself to the surface of new blood vessels. After this, the doctor shines a light into the patients eye for about 90 seconds to activate the drug. The drug, once activated, will destroy the new blood vessels and helps slower down the rate of vision decline. It is topical and aims only at the new blood vessels, so it does not destroy surrounding healthy tissues and cells like the laser surgery.

However, caution has to be taken with the use of this drug. As it gets activated by lights, patient has to avoid going outdoors, or exposing skin or eye to direct sunlight or bright indoor lights for five days after treatment. Remember that the drug is administered through injection on the patient’s arm, and the fact that it travels throughout the body instead of being contained within the eye.

This treatment is basically painless, and can be performed at the doctor’s office in about 20 minutes. However, while it slows down the rate of vision loss, it does not stop vision loss, or restore the patient’s vision if it was already damaged by ARMD. Again, this technique will require repeated treatments as necessary, based on the doctor’s prescription and the progress of your condition.

Another treatment is the use of injection, this time with new drugs that are injected directly into the eyes. The anti-VEGF therapy will see these new drugs block the effects of the specific growth factor that triggers the abnormal blood vessels. Multiple injections will be required, and it can be a monthly affair. Before injection, the eyes are numbed. After injection, the patient will be kept at the doctor’s office for a while so that the doctor may monitor the progress of the eyes before declaring that the patient is safe to go home. It is said that this treatment helps slow down vision loss from ARMD and may also help to improve the sight of patients in some cases.

In any of these treatments, the patient should listen to the doctor because the doctor will know the best option available for each individual.

Zeaxanthin For Macular Degeneration Prevention and Treatment in Dry AMD

2010-12-20T05:47:00.000-08:00

by The Pulitzer
Most ophthalmologists recommend the antioxidants lutein and zeaxanthin for macular degeneration that is age related, commonly referred to as AMD. It is unusual for doctor’s to recommend nutritional supplements of any kind, unless a person has an outright deficiency, but AMD is a unique condition.

There are no effective treatments for one type of AMD (dry), but there are some partially effective treatments for wet AMD. Together, these two are the major causes of blindness in the elderly. The wet form is the most severe, if not treated early.

In wet AMD, blood vessels grow up and behind the retina, an area responsible for gathering light and transmitting signals to the brain, resulting in sight. The blood vessels often rupture and leak blood and protein below the macula, a very sensitive area within the retina.

Eventually, bleeding, leaking and scarring causes irreversible damage to the light receptors (rods and cones). Rapid vision loss is experienced if it is left untreated. Laser treatment and drugs that inhibit blood vessel growth are usually recommended.

Generally, doctors recommend lutein and zeaxanthin for macular degeneration that is of the dry type. Dry AMD is much more common than wet. It is caused by a build up of yellow deposits called drusen on the retina.

In nature lutein and zeaxanthin are pigments or colors. They are normally present in the retina, with zeaxanthin being concentrated in the macula and lutein more highly concentrated in the periphery of the retina. There roles within the eye are not well understood, but they seem to help reduce or prevent the build up of drusen.

Drusen is similar in composition to the deposits that are found in the brains of Alzheimer’s patients and the plaque that is present in atherosclerosis. People with either of those two conditions have a higher risk of developing dry AMD.

Some doctors recommend taking lutein and zeaxanthin for macular degeneration prevention, particularly to their patients that have a family history of the disease. But, since the drusen are similar to the deposits that cause Alzheimer’s and heart disease, other antioxidants may be beneficial, as well.

Curcumin, an antioxidant present in the spice turmeric, is currently being studied for its benefit in Alzheimer’s disease. Not only does it prevent the accumulation of the plaque, it breaks it up. It might be able to break up the drusen in AMD, too.

One study indicates that the ideal combination of nutrients is omega 3 fatty acids, beta carotene, vitamin E, lutein and zeaxanthin for macular degeneration. Omega 3 fatty acids, particularly DHA, are the most abundant fatty acids present in the retina. Beta-carotene is converted by the body to vitamin A, which is essential for good vision. Vitamin E is well-known for its antioxidant activity.

Prevention is worth a pound of cure, they say. In order to prevent AMD, people should lower their total fat intake, and increase their nutrient intake. This may help reduce the risk of many other diseases, as well. Taking zeaxanthin for macular degeneration prevention is a good idea. Taking a multi-nutritional supplement that contains it, is a great one.

Valerie Rosenbaum researches omega 3 fish oil supplements, anti aging supplements and natural skincare products. Through her research she has discovered the best anti aging supplement, in both quality and value, available today.

Advance Cell Technology's CEO says Markets Are Just Starting to Appreciate the Significance of Thei

2010-12-11T06:43:00.000-08:00

by Advance Cell Technology

The excitement around ACTC comes after a recent series of key positive announcements including the fact that the FDA granted orphan drug status to the micro-cap's patented embryonic stem cell derived treatment for specific forms of Macular Degeneration and blindness (Stargardt's Macular Dystrophy and Dry Age-related Macular Degeneration). The eye conditions destroy the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells.

The condition destroys the pigmented layer of retina (retinal pigment epithelium) which is the pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells. Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and can potentially take only a few weeks to show positive results.

Advanced Cell Technology has shown success introducing the embryonic stem cell derived RPE cells into the eye in animal models and this resulted in 100% improvement with no side effects for more than 220 days. Human clinical trials are expected to start in the first quarter of 2011, and could potentially take only a few weeks to show positive results according to some analysts.

In addition, for only the second time in history (following Geron's therapy for spinal cord injury), the FDA granted approval for clinical trials for a therapy derived from human embryonic stem cells.

William M. Caldwell, Chairman and CEO of ACTC tells BioMedReports that ACTC plans on building upon their orphan drug status and accelerating clinical testing. In addition, they hope to continue showing promising advancements in other forms of regenerative medicine which the company is developing -- most notably its Myoblast program for the treatment of heart failure. The Myoblast program (part of the company's 2007 acquisition of Mytogen, Inc.) has successfully completed Phase I human clinical trials and the FDA has finished reviewing the data, thus allowing Advanced Cell Technology to proceed with a Phase II human clinical trial (in approximately 160 patients) early next year.

BioMedReports: It appears that suddenly your company has a lot of attention given your news developments. What do you make of all the activity in your stock during recent days?

William M. Caldwell, Chairman and CEO of ACTC: The market is starting to appreciate the significance of the FDA approval of our particular therapy. I think they are now beginning to understand the strategy of having filed for an orphan indication designation for Stargardt's Macular Dystrophy (SMD is one of the most common forms of juvenile macular degeneration in the world) and they now realize that that represents the first wave, with potentially huge commercial opportunities in Dry AMD (Dry Age-Related Macular Degeneration reportedly afflicts more than 30 million people worldwide, including an estimated 13-15 million Americans). Both indications do not have viable therapies and so to the extent that our program can make an impact, it's going to not only help a very large patient population, it -- as well as any other therapies that are approved -- will help validate a very large technology.

BioMedReports: Can you help us digest or simplify what some of those implications are?

William M. Caldwell, Chairman and CEO of ACTC: I can certainly try. Right now, Genentech has a drug on the market for Wet AMD [Note: the FDA approved Lucentis in 2006 after a 6-month priority review] and that patient population is substantially less than the Dry AMD component. Their procedure is to apply a needle into the eye every two to three months with their therapy and for that they get some $2500, plus or minus, for each injection. In our particular situation, we are inserting a needle into the eye- which is something that is done all the time, by the way, this isn't something that's foreign to the practitioner that does the application -- but our application takes place only once or possibly twice over the life of the patient. It is our expectation that the therapy which we'll apply will have an impact on either slowing down or arresting the progression of the disease. We've seen that in our animal models. There have been some very dramatic results when we've applied it into animals and we are extremely hopeful that we will see the same types of results when we apply it into humans.

The problem has been that this technology is totally new to the world of medicine. It is an embryonic stem cell derived therapy. It turns out that our cells have been derived utilizing what we call a blastomere technology which means that we have been able to develop those stem cells without any embryo destruction, which somewhat mitigates the issues that have been in the media.

So, we take our particular stem cell therapy -- and remember that the stem cells are converted into a single cell type so there's really no actual stem cells into the therapy that we are applying only a certain cell-type and in this particular case, it's what they call RPE (retinal pigment epithelial) cells. That RPE layer is in the eye between the photoreceptor and the Bruch's membrane. It protects that photoreceptor -- which gives us the ability to see -- and it also nourishes it. With deterioration, all sorts of different diseases occur. One of which is Stargardt's Macular Dystrophy and another of which is Dry AMD. Now, there are certainly different characteristics to those, but to the extent that you can replenish that RPE layer with new, healthy, viable cells you have the opportunity to dramatically impact the deterioration that is occurring within the photoreceptor.

That's a layman's description of what we're doing with respect to that therapy, but more importantly the market implication is such that if you have in excess of ten million patients currently suffering from that disease; which is age related and as we know the baby boomers are getting older. Unfortunately for those of us that are getting into that post fifty-five or sixty year-old age range, those individuals are prime candidates for this disease. That market is fairly significant. There is an opportunity of tremendous magnitude for a company like ours.

BioMedReports: Let's talk about the structure of the company for a bit. There have been some concerns that there are a lot of shares out there and that a company that is set up in this way could suddenly announce something like a reverse-split during a run-up in price like this one. What are your comments in regard to that as far as ACTC goes?

William M. Caldwell, Chairman and CEO of ACTC: I'm an investment banker and I can tell you that it has been my experience that reverse splits for the sake of reverse splits are very problematic. There has to be a rationale behind why someone would do such a thing and it has to be done around some sort of event that is accretive to shareholders and makes logical sense for all the stakeholders. I'm not inclined at all to recommend a reverse split unless that opportunity presented itself. If it does, based upon our charter, we would then have to go to the shareholders for their approval. In that way they would have an opportunity to understand our rationale and determine whether that makes sense for the majority of them. I think that's about all I can say about that subject at this stage.

BioMedReports: Can you talk about any of the upcoming milestones for the company? Some think that is part of the reason for this run-up, that there are some events worth looking forward to on the horizon.

William M. Caldwell, Chairman and CEO of ACTC: I think we've alluded to some things a couple of times either on blogs or in conferences, and I can start with the approval of our IND for Stargardt's Disease which we will be seeing some time in the first half of the coming year. (That will mark) us going into the clinic. And we have already alluded to the fact that we will go into multiple sites, not just one particular site, for the reason that we have filed for Phase I/Phase II. For those who are not familiar with that, Phase I really focuses on safety. That's going to be a very, very important piece, not just because of the safety, but because it will ensure for the FDA that this cell type can be safe in humans.

You know the first one is always the toughest one, so we've designed the trial to be very, very slow in its evolution. We have a dosage escalation schedule whereby we're only inserting a minimal amount of cells at the outset per patient. Then we will increase that with ensuing patients and we'll pause to allow the FDA to review the results of that so that they can feel comfortable with the safety issues related to the fact that the cells go where they are supposed to go and do what they're supposed to do and that they don't cause any side effects, or tumors or anything else that has been ballyhooed around. By the way, we have never, in any of our studies, ever seen that.

So, I can't speak for others, but for us; our patented differentiation processes are such that our cells are terminally and totally differentiated into the cell type that we're dealing with. Once we do that, then we'll move quickly into efficacy and that tells us, of course, "does it work?" And that's why we're starting out with multiple sites. Right now, I'm in the process of finalizing those sites and developing a relationship with the primary investigator -- the surgeon at each of the sites. I'm working with the internal review boards to gain approval on the protocols on any specific issues that they may have relative to their particular situation and then we will initiate those trials when all of that is completed.

The second major milestone is that we've filed a second IND. That one is for the Dry AMD and we anticipate that it will take much less time for the FDA to evaluate that, versus the time they took to evaluate the first one. We anticipate that sometime in the first quarter (of 2011) there is a very reasonable chance that we will see approval for that IND -- at which time we will then initiate trials for that program as well. Just so you know, it's the same cells. So we're really just taking the same cell-type and treating a different disease-type. So that's why we're relatively bullish on that particular program.

A third area that we've announced is that as big as the market is, and the opportunity is here in the United States, the European community offers a similar opportunity. And with the E.U. controlling the regulatory perspective for the various countries on the continent, we will be looking very hard at the opportunity to take both our Stargardt's and Dry AMD programs over there. I've been spending some time over there trying to ascertain what the best way is to do it and where the best places are to initiate the trials as well as learning a little bit about the process of how to work through the regulatory situations over there. We should be in position to make an announcement about that in the first half of next year.

We've also mentioned another disease condition called our Myoblast or heart program. It's an adult stem cell -- meaning it's the patient's own cells -- in this particular instance. We extract out of the thigh in a biopsy and then we re-place it into the heart with a catheter system. Basically, it goes over the dead heart tissue from a heart attack that a patient has had. And what those cells do, those myoblast cells, is they integrate with the good cardio myocyte cells -- the heart cells -- and help those cells pump the blood in and out of the heart. That's important because when you have a heart attack, part of your heart muscle is killed or dead, and unlike other parts of the body the muscle doesn't regenerate itself and so the remaining muscle has to work harder and the heart becomes a little weaker. Because of the strain on the muscle it gets, sometimes, enlarged. The walls get thinner and that's when you start seeing heart failure. What this does is that it helps mitigate that and the patient can start feeling better. That's really where the FDA is focused on, is the quality of life of the patient. Most of the patients that we're dealing with are in advanced age heart failure. So that is another disease condition. We have gotten approval from the FDA to move out of the Phase I, where we did four trials, and we're moving into Phase II. I've made an announcement that we intend to do that in the first half of next year. So again, that is another program that you should be hearing some things from us about during the first half of next year.

So just in the first half of the coming year we have some fairly significant milestones that we have before us and then there are a couple that we're working on now that we haven't announced yet.

Vitamin C For Macular Degeneration

2010-12-07T03:31:00.000-08:00

by Admin

Some of the vitamins that can help when it comes to protecting eyesight and reducing or preventing age macular degeneration includes Vitamin C, E, Thiamine, Riboflavin, B-6, B12, Folic Acid, Niacin, Zinc, L-Taurine, Manganese, Copper, Selenium, Calcium, L-Glutathione, Rutin, Lycopene and Lutein. All of these vitamins have properties that help to increase eye health and increase the body’s ability to reduce the effects of macular degeneration for example these vitamins may help in the reduction of blood vessels or the reduction of Drusen that buildup between the macula and the retina. Improving your eyesight can also help to reduce symptoms in the beginning stages of macular degeneration.

Retinal Disease Treatments Double Over 10 Years

2010-11-28T09:48:00.000-08:00

by:Jen Blackstock

When most people think of diabetes, the first thing to come to mind is rarely blindness, yet blindness is a very real complication of diabetes: Diabetes is actually the number one cause of new blindness in the United States.

Diabetic retinopathy happens when diabetes damages the tiny blood vessels inside the retina, which therefore stop feeding the retina properly, according to the American Foundation for the Blind. Symptoms can include blurry or double vision; rings, flashing lights or blank spots; dark or floating spots; pain or pressure in one or both of your eyes; and trouble seeing things out of the corners of your eyes. Forty percent of people with diabetes have some form of diabetic retinopathy.

With the rise in the number of people with diabetes and the aging American population, it is no surprise that the number of older Americans undergoing treatment for retinal conditions such as age-related macular degeneration (AMD) and diabetic retinopathy increased 192 percent between 1997 and 2007. Additionally, there has been a significant shift in the types of procedures being performed, a new study has found.

Age-related macular degeneration is a progressive disease of the retina that causes the loss of central vision. Both age-related macular degeneration and diabetic retinopathy can cause vision loss and blindness.

The study analyzed Medicare data from 1997 to 2007 and found that the number of retinal procedures increased 192 percent during that period. The largest year-to-year increase (20 percent) occurred between 2006 and 2007, according to the study published in the October issue of the journal Archives of Ophthalmology.

In terms of actual procedures performed, the largest increase was in treatments for neovascular, or "wet," AMD. New treatments for this condition include intravitreal therapy, or drug injections directly into the eye, of antibodies that block the formation of new blood vessels. From 1997 to 2001, only 5,000 of these procedures were performed each year. By 2007, the number had jumped to 812,413. Also increasing is the use of vitrectomy, a surgery to remove the gel inside the eye in order to treat retinal detachment -- increased 72 percent between 1997 and 2007.

"Retinal disease is highly prevalent among older individuals, and both age-related macular degeneration and diabetic retinopathy account for more than half the irreversible blindness in older Americans. The prevalence of both macular degeneration and diabetic retinopathy increases with age, and the number of Americans affected by these conditions is expected to increase substantially as the number of Americans older than 65 years doubles from 2010 to 2040," says study author Dr. Pradeep Ramulu, of Wilmer Eye Institute at Johns Hopkins University in Baltimore.

With the rise of cases of diabetes and the aging of the baby boomer population in the United States, eye care and blindness prevention is becoming increasingly important within the medical community.

New Techology Detects Retinal Disease

2010-11-22T11:11:00.000-08:00

by Martha L. Hernández

McALLEN — For years, the only way for doctors into the back of the eye for a retina inspection involved special eye drops, which dilated the patient’s pupils and required the wearing of dark glasses for hours after the exam.

Now, scientists have developed the Optomap Retinal Exam, which eliminates the need for drop. Patients only see a quick, green flash of light.

“This test is a non-invasive way of doing it. We don’t put drops in your eyes, we just take a picture of the back of your eye and under 25 seconds (later), it gives us a 3D image. We can review the image with you on the computer (immediately after),” said Dr. Fiona Kolia, a therapeutic optometrist at Astoria Vision Source.

“We can look at it with different filters. This test is very important because it allows us to tell you about the health not only of your eye — where we can detect (diseases like) glaucoma (or) macular degeneration, any holes or tears, anything that is in the eye that shouldn’t be there — it also tells us about the health of your body,” Kolia said.

The new technology has detected other medical conditions in people seeking glasses or contacts.

“For example, a young person, healthy, walked in and he had a hemorrhage in his eye that is caused by high blood pressure, and high blood pressure is a silent killer, you refer them (to their family doctor) and they can start to get treated and take care of themselves,” Kolia said. Undetected high blood pressure can lead to strokes and other serious complications, Kolia noted.

“Sometimes we are the first to detect if the people have signs of high blood pressure, diabetes, high cholesterol, any arteriosclerosis in the eye and we refer them to their family physician” Kolia said.

Kolia is the only optometrist south of Corpus Christi that has an Optomap.

“Sometimes people just don’t see well and they might think it’s just their glasses” Kolia said. “There was a gentleman that had a macular degeneration that needed to be treated … but sometime in younger people (that) kind of problem happens due to high stress and the macular area (center of the eye) can become swollen and you can lose your central vision (if you do not treat it),” Kolia said.

“What we hope to do is be able to screen a lot of people, I think that in this area it is very important for diabetics. We want to it as a tool and make people aware that an eye exam not only involves getting you a better pair of glasses, it involves looking at the interior structures of the eye and behind the eye,” which can aid in the detection of numerous health issues, Kolia said.

Insurance companies do not typically cover treatment with an Optomap. If there is a definite medical diagnosis it may be billed as a retinal photo in some instances with some insurance plans. Patients without insurance pay $37 for the test.

“In a lot of people who are nearsighted, the eyeball elongates, so it is important to look behind the eye because they can develop a retinal detachment,” Kolia said.

Kolia said the Optomap likely would be added to the regular battery of tests conducted by optometrists and ophthalmologists during routine eye exams as the technology comes into more widespread use.

Limited Retinal Translocation for Wet Macular Degeneration

2010-11-15T19:02:00.000-08:00

Posted by Administration

Limited Retinal Translocation-Limited retinal translocation is another treatment aimed at wet macular degeneration. In this procedure the retina is actually moved somewhat to allow laser treatments to be applied more successfully to abnormal blood vessel growth. The procedure is still in the macular degeneration treatments developmental stages in terms of approval for commercial applications. Surgical options for dry macular degeneration are proposed periodically. The methodologies change from procedure to procedure, but the general idea is the same.

Eye Implant breakthrough

2010-11-04T05:41:00.000-07:00

By Andrew Hough
Eye implant breakthrough: scientific advances towards a blindness cures
An eye test is the only way to diagnose glaucoma, the leading cause of blindness in Britain.

* Stem cells grown on contact lenses could be a cure for a common cause of blindness, claim scientists. Australian researchers said that the world breakthrough could "dramatically improve" the sight of patients with damage to their cornea – the clear outer shell of the eye – caused by disease or injury.

The research team removed tissue with regenerative stem cells from patients' own eyes and then multiplied them in the laboratory on the surface of a contact lens. This was then placed back onto the damaged cornea for 10 days, during which the cells, which can turn into any other sort of cell, were able to recolonise and "patch" the damaged eye surface. Within weeks the patients saw dramatic improvements in their vision. If early findings bear out then the treatment could be affective for thousands of patients in Britain and is so cheap it could be used for millions more in the Third World.

* Artificial corneas grown in the laboratory were transplanted into patient's eyes for the first time in an operation, scientists reported. The new technique involved growing human tissue or collagen in the laboratory and then shaping it using a contact lens mould.

Damaged and scarred tissue from the front of the eye is then removed and the "biosynthetic" replacement is stitched in its place. Eventually existing cells and nerves in the eye grow over the artificial cornea incorporating it fully into the eye.

* Eye cells that are sensitive to light were produced from skin in a breakthrough that could eventually lead to treatments for blindness, scientists reported in August. Researchers genetically “reprogrammed” human skin cells to possess the same properties as those that make up the retina.

The process involved first turning them into pluripotent stem (IPS) cells, which have the potential to develop into virtually every kind of tissue in the body. By exposing the IPS cells to a specific cocktail of chemicals, the scientists then caused them to grow into partially developed retina cells – the light-sensitive cells at the back of the eye which transmit nerve signals to the brain.

* Patients who were left blinded after chemical accidents have had their sight restored using corneas grown from their own stem cells, scientists claimed in June. In the largest study of its kind, Italian researchers said they restored the sight of patients left blinded or suffered severely impaired vision, after suffering chemical burns.

Experts said the study, undertaken between 1998 and 2007, offers new hope to the thousands of people who suffer chemical burns on their corneas from heavy-duty cleansers or other substances at work or at home. The research is also being hailed as a key breakthrough in scientific regeneration that could give hope to other patients with otherwise irreversible eyesight.

* Also in June, a new study suggested a simple way to stop you eyesight deterioriating - drinking red wine. Researchers have found that a substance found in grapes and other fruits could protect blood vessels in the eye being damaged by old age. It is effective because the compound, known as resveratrol, stops the blood vessels from being damaged.

The substance, which has been linked to anti-ageing and cancer protection in the past, is believed to work because it protects against abnormal angiogenesis – the formation of damaged or mutated blood vessels. This condition is linked to cancer, heart disease and eye diseases such as age-related macular degeneration. In the study, reported in the New England Journal of Medicine, researchers successfully extracted adult stem cells from healthy eye tissue before growing additional stem cells that were placed over damaged eye tissue.

* Gene therapy was used by American scientists to improve the vision of children with hereditary blindness. US doctors treating 12 patients with a rare genetic eye disorder were able to significantly improve vision in the youngest, according to medical journal The Lancet. The research, which builds on work carried out by doctors at London's Moorfields Eye Hospital, focused on Leber's congenital amaurosis (LCA), a disorder which causes gradual deterioration in vision and can lead to blindness by the time the patient is 20. It occurs when faulty genes, called RPE65, stop the layer of cells at the back of the eye working and affects approximately one in 80,000 people. It is responsible for one in 10 severe sight disorders in children.

* Scientists cured colour blindness in monkeys, in what some were signalling has new hope for millions of sufferers of the condition. Researchers reported last September that they cured the animals using a treatment called gene therapy. A harmless virus which delivers corrective genes to the retina was injected into the eyes of two squirrel monkeys, Dalton and Sam, who had been colour blind since birth. Within weeks a protein produced by the corrective genes allowed both monkeys to make out reds and greens for the first time. They can still see the colours two years later. The breakthrough could also have implications for other damaging genetic eye defects, including those which can cause blindness, after researchers proved for the first time that the brain can “rewire” itself to see things it has never been able to before.

* A new eye drop treatment was offered to help preserve the sight of thousands of people at risk of going blind due to glaucoma, scientists reported. The drops were first of their kind that avoid unpleasant side effects which deter up to a third of patients from continuing their treatment.

Many patients simply refuse to apply the drops because of the discomfort, thereby putting themselves at risk of vision loss. Regular use of the eye drops can keep the condition under control for a patient's life time. Without them, a patient can go blind in five to 10 years. When the disease becomes too advanced the only remedy is surgery, which is risky and may itself result in blindness.

Telescope Implant Improves Vision in Macular Degeneration

2010-10-30T13:18:00.000-07:00

by Kathleen Louden
(Chicago, Illinois) — People with end-stage age-related macular degeneration (AMD) have improved visual acuity and quality of life after receiving an intraocular implant containing a tiny telescope in 1 eye, new research shows. An ophthalmologist who participated in the clinical trials presented the unpublished results here at the American Academy of Ophthalmology and Middle East Africa Council of Ophthalmology 2010 Joint Meeting.

The telescope implant improves vision in "a disease in which the patient is legally blind and has no surgical or medical alternatives," the presenter, Stephen Lane, MD, told Medscape Medical News. He was a medical monitor for the pivotal trials and is an adjunct professor of ophthalmology at the University of Minnesota, Minneapolis.

In July, the US Food and Drug Administration approved the telescope implant, also called the implantable miniature telescope (VisionCare Ophthalmic Technologies), to improve vision in some patients with end-stage AMD.

Telescope Magnifies Images More Than 2 Times

"The reason why this [device] works is a magnification effect, so the central scotoma can be overcome," Dr. Lane told meeting attendees.

This pea-sized implant, which replaces the natural lens, magnifies images greater than 2 times and projects the images onto a healthy part of the retina, according to the device manufacturer. It is available in 2 models: 1 that provides 2.2 times the magnification and another that gives 2.7 times magnification. Patients use the eye that received the implant for central vision and use the untreated fellow eye for peripheral vision.

To be eligible for this class 3 medical device, patients must have bilateral geographic atrophy or "post-wet" AMD disciform scars and must not yet have had cataract surgery, although they can have cataract, Dr. Lane said. Other eligibility criteria, according to the US Food and Drug Administration, include age 75 years or older and "stable severe to profound vision impairment" resulting from bilateral central scotoma.

In a multicenter clinical trial of more than 200 patients who received the implant, the mean best corrected visual acuity before implantation was worse than 20/300, Dr. Lane said. More than 80% of patients had at least a 2-line improvement in visual acuity on the Snellen chart 1 year after surgery, and 46% of patients improved 4 lines or more at 1 year, he reported. Most of those patients, according to Dr. Lane, maintained their improved visual acuity 2 years postoperatively (75% with 2 lines or better and 43% with 4 or more lines of improvement).

"Quality of life gains also are clinically meaningful," Dr. Lane said. "Patients were less dependent, better able to recognize people, and better able to...do activities of daily living."

Endothelial Cell Loss Possible

A possible complication of the implant is the loss of corneal endothelial cells. In the study, there was a 20% loss of epithelial cells, which Dr. Lane called "a little high." He said ophthalmologists should inform their patients that substantial endothelial cell loss can lead to corneal decompensation and the need for a corneal transplant.

A Michigan ophthalmologist who did not participate in the studies, George Williams, MD, said in an interview that study investigators told him that most patients in the studies tolerated the implant well and found it very helpful.

However, the device is for "a select group of patients with end-stage AMD," said Dr. Williams, chairman of the Department of Ophthalmology at Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.

He mentioned, as did Dr. Lane, that patients need to undergo an evaluation to determine whether they can benefit from this device, which involves a trial with an external telescope.

"Only 1 in 5 patients who are screened actually end up getting the device," Dr. Williams told Medscape Medical News.

After the surgery, patients must receive training with a low-vision specialist. "It's hard to walk around with a telescope in your eye," Dr. Williams said.

Patients who did not tolerate the implant were those who could not adjust to using 1 eye for near-vision tasks and the other eye for distance vision, Dr. Lane said during the meeting.

Gene Therapy/ Treatment for Visual Impairment

2010-10-26T05:36:00.000-07:00

Gene Therapy For Visual Impairment
By: Mark Burnsy

In modern society where most people are educated, eyesight problems inevitably proliferate, due to the fact that they have spent more time in reading. TV and computers are also incentives of the skyrocketed eyesight problems. Owing to the invention of eyeglasses and contact lenses, people with nearsightedness, farsightedness, astigmatism and presbyopia are able to view a clear world as well. Additionally, fast developed, eyeglass manufactures achieve advancement in glare reduction and unwanted wavelengths of light elimination.

However, eyeglasses and contacts can not serve as helps for vision improvement of people suffering from eye diseases, such as Macular Degeneration and Diabetic Retinopathy. Recently, a medical treatment is developed, which is also able to treat visual impairments. Avastin is a drug that was originally used in Colo-rectal cancer treatments but is found to have an ability to improve the vision in patients with Macular Degeneration, Diabetic Retinopathy and other vascular related retinal diseases. What's more, many other new drugs are brought about in succession as well, for example, the non steroidal anti inflammatory drugs can reduce retinal inflammation and cyst formations.

There are some people whose eye diseases arise from within the patients, genetic and congenital disorders. They pose a great challenge to eye doctors and surgeons. Luckily, gene therapy is found to be able to dramatically improve those patients' vision. The procedure is performed at the Scheie Eye Institute in Philadelphia and the patients formerly suffering from Leber's Congenital Amaurosis claim that he could read letters on an eye chart already after such a procedure. Then the news was published in the New England Journal of Medicine, on which the cause of Leber's Congenital Amaurosis and how the surgery achieves an success are recorded. It is stated that a lack of RPE 65 gene prevents protein production which is required for the retinal tissue to absorb and process the light into vision. A normal RPE is injected in the gene therapy to restore the protein production. After two weeks, the patients can mostly view more clearly than they did before. Possible complications of gene therapy include sensitivity to light.

In spit that it is just a successful case of Leber's Congenital Amaurosis treatment, it gives hopes to other eye diseases originated from gene disorders. Researches concerned are under procession. The application of gene therapy in visual impairment will be a great success in the near future.

NeoVista Presents One-Year Study Results of Novel Therapy for Treatment of Neovascular Age-Related Macular Degeneration

2010-10-17T13:27:00.000-07:00

NeoVista, Inc. made public today at the American Academy of Ophthalmology meeting the company’s one-year results from their MERITAGE Study. This study was designed to examine NeoVista’s novel Epimacular Brachytherapy procedure when used in patients who require chronic therapy with anti-VEGF agents on an ongoing basis to control Neovascular Age-Related Macular Degeneration (Wet AMD). The study enrolled patients who had as many as 38 prior injections of anti-VEGF therapy before receiving Epimacular Brachytherapy. The study population had a trend toward losing vision, even with regular anti-VEGF therapy in the year prior to enrollment. Prior to entry into the study, all patients were required to have received a loading dose of 3 monthly anti-VEGF injections and then a minimum of 5 additional injections in the 12 months preceding enrollment or 3 injections in the 6 months preceding enrollment. This ensured that the full benefit of anti-VEGF therapy was realized prior to entry into the study.

Study results (n=53) to date suggest that a single procedure of Epimacular Brachytherapy can stabilize visual acuity in a majority of this patient population (79%) while decreasing the number of anti-VEGF injections required. Most importantly, 47% of patients enrolled in the study experienced some improvement in their visual acuity while 10% of patients gained 15 or more letters of visual acuity at 12 months. This improvement is significant in patients that have been receiving chronic anti-VEGF treatment with no vision improvement in the year prior to enrollment, as compared to all other trials that are treating patients with newly onset disease.

The study results also pointed to a favorable trend with respect to a reduced number of anti-VEGF injections following delivery of Epimacular Brachytherapy (mean of 3.9) versus the period of time leading up to Epimacular Brachytherapy intervention (mean of 12.3). In addition, 25% of patients remained injection-free at 12 months following the Epimacular Brachytherapy procedure.

“MERITAGE is the first of its kind study designed to evaluate the potential role of the NeoVista device in treating chronic disease and decreasing the burden of treatment while maintaining or improving visual acuity,” said John N. Hendrick, President and CEO of NeoVista. “Data from recent randomized trials suggest that most patients suffering from Neovascular AMD will require anti-VEGF treatment on an ongoing basis for an indefinite period of time. We are very excited that our procedure, Epimacular Brachytherapy, not only has the potential to significantly decrease the number of injections administered but may also improve visual acuity in a significant percentage of this patient population.”

In contrast to other forms of radiation therapy for Neovascular AMD, NeoVista’s approach delivers a focused dose of energy directly to the wet AMD lesion without damaging the adjacent healthy retinal vasculature. Utilizing strontium 90, the targeted energy is delivered to a an area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal and highly controlled to a local area. The effective dose to the entire body from NeoVista’s device is less than that from a typical chest x-ray. There were a limited number of adverse events in the trial, which were related to the surgical vitrectomy procedure, rather than Epimacular Brachytherapy.

The MERITAGE Study was conducted in two centers in the Unites States, one center in the United Kingdom, and two centers in Israel. Principal investigators were Pravin U. Dugel (USA), Michael D. Bennett (USA), Timothy L. Jackson (UK), Adiel Barack (Israel), and Dov Weinberger (Israel). The data was presented by Pravin Dugel, MD, managing partner, Retinal Consultants of Arizona, Phoenix, AZ. “The potential of this treatment is enormous,” said Dr. Dugel, “as this patient population represents the majority of patients that I see in my clinic each and every day. I believe that Epimacular Brachytherapy, unlike anti-VEGF therapy alone, offers a broad spectrum of activity and may therefore inhibit multiple disease processes involved in the pathology of wet AMD. To observe not only a reduction in treatment burden, but also an improvement in visual acuity in almost half of these difficult to treat patients at the one year mark is quite encouraging.”

NeoVista completed enrollment in the company’s first pivotal trial, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that has enrolled over 490 subjects at 45 sites worldwide, and is evaluating the safety and efficacy of NeoVista’s therapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis® (ranibizumab) versus Lucentis alone.

A second pivotal trial MERLOT (Macular EpiRetinal Brachytherapy versus Lucentis® Only Treatment), sponsored by King’s College Hospital, London, England, (Principal Investigator-Mr. Tim Jackson), is being conducted in 20 centers throughout the United Kingdom. MERLOT is also a randomized, controlled study, with targeted patient enrollment of 363 subjects. This study is analyzing the effects of Epimacular Brachytherapy used concomitantly with as needed Lucentis injections versus continued Lucentis therapy alone, in patients who require chronic therapy with anti-VEGF agents on an ongoing basis to control Wet AMD.

About NeoVista, Inc.

NeoVista, Inc. is a privately held medical device company based in Newark, California. The company’s first commercial product, VIDION® ANV® Therapy System, is cleared for commercial use in all markets that accept a CE Mark.

For more information about the company, or this novel therapy, please visit the company’s Web site at www.neovistainc.com.

# # #

Vocus©Copyright 1997-2010, Vocus PRW Holdings, LLC.
Vocus, PRWeb and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.

Movie: Twelve Kingdoms – Chapter 7 – Reflection http://bit.ly/9KqKJi – by kitanoau (Kitano Holdings P/L)

The Twelve Kingdoms episode 39-1 (Audio English) /45

The Twelve Kingdoms episode 39-1 (Audio English) /45
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Tagged as: AgeRelated, Degeneration, Macular, Neovascular, NeoVista, novel, OneYear, presents..., results, Study, Therapy, Treatment

{ 25 comments… read them below or add one }

MrJustletmeseeit October 16, 2010 at 12:39 AM

@gr8Sweetfox Ok, what if we stuff the nuke with pixies and unicorns?

Reply
gr8Sweetfox October 16, 2010 at 1:23 AM

@MrJustletmeseeit that wouldnt happen. at least the trees.. i mean this special trees are never affected.. they seem to be impossible to destroy

Reply
MrJustletmeseeit October 16, 2010 at 1:55 AM

@gr8Sweetfox what if the nuke slips thru and detonates while tentei is yawning? or getting it on with some hot goddess…

Reply
RokenMusic October 16, 2010 at 1:56 AM

@gr8Sweetfox As for your question about the princess’s palace song. I do not believe an official attempt of dubbing it into English was ever made. There might be fan made videos floating out there. I recommend you search the first line of the song’s lyrics for these. Good luck.

Reply
RokenMusic October 16, 2010 at 2:33 AM

@gr8Sweetfox 12 Kingdoms is very unique in that it is what I would like to call “a Fantasy Opera”, in which the characters are vivid and the central storyline lives within an epic world of continuous stories. This kind of anime are very hard sells because it requires the anime studios to invest heavily and risk utter failure. However, there are a few out there that are on similar caliber. One is Legend of Galactic Heroes. Unfortunately it is science fiction rather than fantasy.

Reply
gr8Sweetfox October 16, 2010 at 3:00 AM

@RokenMusic something like 12 kingdoms with anime?
ps, you were fast. And maybe you know something about the english dubbed version of Sho something. You know that song about a doll… maybe you know something i want it in english so badly ugh i would even pay for it ;__;

Reply
RokenMusic October 16, 2010 at 3:29 AM

@gr8Sweetfox EVA: Neon Genesis Evangelion
LoGH: Legend of Galactic Heroes
Ronin Kenshin
Cowboy Bebop
Trigun
Black Lagoon
and the list goes on depending on your tastes.

Reply
gr8Sweetfox October 16, 2010 at 3:58 AM

@RokenMusic ok , what is EVA, LoGH, and etc. ?

Reply
gr8Sweetfox October 16, 2010 at 4:49 AM

@MrJustletmeseeit nah it would not. Tentei protects their world.

Reply
MrJustletmeseeit October 16, 2010 at 5:16 AM

man… one of todays nukes would take that whole world out =(((

Reply
maihoua19 October 16, 2010 at 6:01 AM

i always felt exciting watching this movie and love it

Reply
endlesssonata October 16, 2010 at 6:25 AM

I love all the Oooohhhh and Aaaahhhhh. So freaking cool!

Reply
endlesssonata October 16, 2010 at 6:55 AM

WOW this one is my favorite ep ever! Youko’s entre is soooo coolll. Now that IS how a queen reveal herself!

Reply
Goatmon October 16, 2010 at 7:43 AM

Youko is the boss, and she’s layin’ down the law.

Reply
Goatmon October 16, 2010 at 7:49 AM

@chebozz Fantasy/Adventure?

Reply
ZRaya99 October 16, 2010 at 8:27 AM

i like how they all laught

Reply
enariuzai October 16, 2010 at 8:51 AM

早く続きが観たいです、続編が再開されたみたいだし＾＾

Reply
afny19 October 16, 2010 at 9:11 AM

if the real world have ruler like this, this world can be a better place… so wise and noble even if that person use to be just a commoner ^^,

Reply
brokenating October 16, 2010 at 10:00 AM

i really love this episode! :D

Reply
zeroEDJE October 16, 2010 at 10:08 AM

For a second there I thought we were going to see the intro.

Reply
chebozz October 16, 2010 at 10:33 AM

hmmm…what is the genre of this anime??

Reply
mancdg627aol October 16, 2010 at 11:26 AM

I love watching this episode over and over again it’s so cool when keiki showed up and youko questioned general jinrai hahaha… The best anime i watched on its genre… I will buy the books an read it…. ^^

Reply
RokenMusic October 16, 2010 at 12:05 PM

@gabaroo59: No, not really. Twelve kingdoms is one of the best light novel series and anime series. Up there with EVA, LoGH, and etc.

I’m surprised that they didn’t do a half bad job at dubbing this anime. The translation is pretty accurate to the original. Although Yoko’s voice is supposed to be more boyish.

Reply
bollywoodgirl21 October 16, 2010 at 12:16 PM

I love yokos speach in the beginning, she just rules!!!

Reply
tearsangelz October 16, 2010 at 12:54 PM

i totally agree<3 all the beasts in this anime is just so awesome!

Reply

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Zeaxanthin For Macular Degeneration Prevention and Treatment for Dry AMD

2010-10-10T05:49:00.000-07:00

by Forrestal

Most ophthalmologists recommend the antioxidants lutein and zeaxanthin for macular degeneration that is age related, commonly referred to as AMD. It is unusual for doctor’s to recommend nutritional supplements of any kind, unless a person has an outright deficiency, but AMD is a unique condition.

There are no effective treatments for one type of AMD (dry), but there are some partially effective treatments for wet AMD. Together, these two are the major causes of blindness in the elderly. The wet form is the most severe, if not treated early.

In wet AMD, blood vessels grow up and behind the retina, an area responsible for gathering light and transmitting signals to the brain, resulting in sight. The blood vessels often rupture and leak blood and protein below the macula, a very sensitive area within the retina.

Eventually, bleeding, leaking and scarring causes irreversible damage to the light receptors (rods and cones). Rapid vision loss is experienced if it is left untreated. Laser treatment and drugs that inhibit blood vessel growth are usually recommended.

Generally, doctors recommend lutein and zeaxanthin for macular degeneration that is of the dry type. Dry AMD is much more common than wet. It is caused by a build up of yellow deposits called drusen on the retina.

In nature lutein and zeaxanthin are pigments or colors. They are normally present in the retina, with zeaxanthin being concentrated in the macula and lutein more highly concentrated in the periphery of the retina. There roles within the eye are not well understood, but they seem to help reduce or prevent the build up of drusen.

Drusen is similar in composition to the deposits that are found in the brains of Alzheimer’s patients and the plaque that is present in atherosclerosis. People with either of those two conditions have a higher risk of developing dry AMD.

Some doctors recommend taking lutein and zeaxanthin for macular degeneration prevention, particularly to their patients that have a family history of the disease. But, since the drusen are similar to the deposits that cause Alzheimer’s and heart disease, other antioxidants may be beneficial, as well.

Curcumin, an antioxidant present in the spice turmeric, is currently being studied for its benefit in Alzheimer’s disease. Not only does it prevent the accumulation of the plaque, it breaks it up. It might be able to break up the drusen in AMD, too.

One study indicates that the ideal combination of nutrients is omega 3 fatty acids, beta carotene, vitamin E, lutein and zeaxanthin for macular degeneration. Omega 3 fatty acids, particularly DHA, are the most abundant fatty acids present in the retina. Beta-carotene is converted by the body to vitamin A, which is essential for good vision. Vitamin E is well-known for its antioxidant activity.

Prevention is worth a pound of cure, they say. In order to prevent AMD, people should lower their total fat intake, and increase their nutrient intake. This may help reduce the risk of many other diseases, as well. Taking zeaxanthin for macular degeneration prevention is a good idea. Taking a multi-nutritional supplement that contains it, is a great one.

Combination PDT, anti-VEG effective for choroidal neovascularization due to AMD

2010-10-04T17:40:00.000-07:00

October 4, 2010
A customized combination of photodynamic therapy and intravitreal ranibizumab treatment for choroidal neovascularization due to age-related macular degeneration achieved good visual results with a decreased need for re-treatment, a study found.

"Combined customized PDT and ranibizumab treatment can achieve visual results similar to those obtained with intravitreal monotherapy with the advantage of fewer intravitreous injections and reduced potential for adverse effects," the study said.

In the nonrandomized, prospective, interventional study, 53 eyes of 53 patients with subfoveal and juxtafoveal choroidal neovascularization secondary to AMD were treated with PDT and intravitreal Lucentis (ranibizumab, Genentech).

At the end of the 12-month follow-up period, subjects' mean visual acuity had improved by 7.2 letters, and 78.8% maintained or improved their initial vision.

"The central retinal thickness and choroidal neovascularization size decreased to 118 µm and 0.26 disc areas, respectively, from baseline to 12 months," the study authors said.

Sixty-five PDT treatments (mean of 1.22 per patient) were performed, and 126 doses of ranibizumab were injected (mean of 2.37 per patient).

In 21 cases, only a single initial dose of PDT and ranibizumab was required.

Advanced Cell Technology Obtains Broad Patent covering use of Stem Cell

2010-09-18T02:07:00.000-07:00

Sep 14, 2010 by Advanced Cell Techno;ogy

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will be issued U.S. Patent Numbers 7,795,025 and 7,794,704 on Tuesday, September 14th, which continue to extend the company's patent portfolio covering its retinal pigment epithelial (RPE) cell programs. In particular, the claims that will issue in patent number 7,794,704 broadly cover methods for treating retinal degeneration using human RPE cells differentiated from human embryonic stem cells (hESCs). Issuing with 68 claims, this patent covers methods of treatment with hESC-derived RPE cells that includes, but is not limited to, Stargardt's disease, retinitis pigmentosa, and macular degeneration. The 41 claims issuing in US Patent 7,795,025 contribute to the development of the company's protection of the processes for manufacturing RPE cells from human ES cells. The patent covers fundamental methods for generating transplantable cells for treatment of human patients.

"Another wonderful milestone for ACT! These patents continue the recognition of the inventions and innovations resulting from our scientific team's ongoing research, and further protects the platform technology underlying our RPE program, one of our key therapeutic programs," said William M. Caldwell IV, ACT's Chairman and CEO. "A valuable addition to our strong intellectual property portfolio, these patents should help position ACT as the dominant player in this potentially very large market. Our RPE technology is safe and scalable, and has tremendous potential for treating some 200 or more diseases of the retina."

"ACT is developing first-in-class treatments for degenerative disorders of the retina," said Robert Lanza, M.D., ACT's Chief Scientific Officer. "The use of RPE cells created from human embryonic stem cells should open the door to potential treatments for many diseases of the retina that impact sight. According to the World Health Organization, macular degeneration alone is known to affect 30-40 million people worldwide, and this represents only a handful of the 200 diseases that may be treated using our RPE cells. We have worked hard to develop an efficient method for producing a renewable source of transplantable RPE cells that can be used to target diseases such as Stargardt's Disease and Age-related Macular Degeneration. For many of these patients there are no available treatments. We have demonstrated that our stem cell-derived RPE cells can rescue visual function in animals that otherwise would have gone blind. We are looking forward to starting our clinical trials with the hope that these cells will be similarly efficacious in patients."

"We believe that these patents are especially important as they extend the company's patent coverage of the scalable manufacturing of human RPE cells for therapeutic use, which are core to our technology and product portfolio," continued Mr. Caldwell. "This IP further expands our patent estate with respect to protecting the use of RPE cells in a wide range of treatments, offering additional validation of the strength and breadth of our patent portfolio. This development also dovetails nicely with the prospect of initiating our human clinical trial for our RPE program. We are optimistic that the methods-of-treatments and the culturing processes covered by these two new patents, along with the Company's proprietary detection technique for final product release, will establish a formidable barrier to entry for any potential competitors. Once we have begun to treat Stargardt patients, we plan to initiate another clinical trial relating to the use of RPE cells in the treatment of dry Age-Related Macular Degeneration (AMD). At present there is no approved treatment for dry AMD, despite the fact that it represents a $20-30 billion potential market."

ACT's Single Blastomere technology used for isolating hESCs does not require the destruction of embryos. The RPE and other hESC-derived cells the company intends to produce for clinical use all begin with these "embryo-safe" stem cells. ACT does not rely on government funding for any of its research or development efforts, and accordingly has not been impacted by the recent court injunction against federal funding of hESC research. Nevertheless, the company's hESC lines and cells made for those lines (such as RPE cells) should fall outside the scope of the court order. While the injunction has been stayed, it is widely believed that this is only a temporary reprieve, with a permanent injunction a real possibility perhaps as early as the end of this month. Should that come to pass, ACT stands ready to offer its human stem cell lines to the research community, pending their approval by the National Institutes of Health (NIH).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "broad," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, scope and enforceability of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-K for the year ended December 31, 2009.

Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

How to prevent age-related macular degeneration

2010-09-12T12:51:00.000-07:00

by Dr Pandula Siribaddana

Age Related Macular Degeneration or ARMD is a common condition seen in the elderly population and can be named as one of the commonest causes of visual loss among the same age group. The condition is characterized by the gradual loss of central vision and could be recognized as having two major categories.

In one form, which is the ‘dry’ macular degeneration, the retina and the layer below in the back of the eye would be separated by cellular debris and in the second form, which is the ‘wet’ macular degeneration, the two layers will be separated by enlarging blood vessels under the retina. In both instances, the peripheral vision would be spared and therefore, these individuals would be able to carry out their daily activities, although the functions such as reading would be impaired to a significant extent.

How to prevent ARMD in the elderly?

The prevention strategies related to ARMD would include avoiding the risk factors which would cause the condition in the first place. Therefore, following prevention strategies can be named as the most useful in order to achieve better vision in the elderly age.
Control blood sugar levels

This has shown to have an influence in the manifestation of macular degeneration and since it is prevalent abundantly, adhering to good glycaemic control would be essential to reduce the disease burden of ARMD.
Avoid smoking

Among the many influences it makes on health, macular degeneration is one and therefore its avoidance would greatly help susceptible individuals to maintain better visual health. According to statistics, there seems to be a threefold risk among the smokers than in non-smokers to develop ARMD during the elderly life.
Control hypertension and cardiovascular diseases

Researchers have identified these two as influencing the occurrence of macular degeneration and controlling of the same would reduce the risk of ARMD in susceptible individuals.
Avoid direct sun light

Sun light, particularly the blue light in the sun’s rays, have shown to influence the functioning of the retina and thus can lead to the development of ARMD. Therefore, using special eye glasses and avoiding such exposure would be recommended for people whom are constantly at risk of being exposed.
Include carotenes in the diet

Carotenes containing foods or else supplements have shown to be effective to a certain extent in reducing the risk of macular degeneration and therefore steps should be taken to include such foods and to take a balanced diet as much as possible.
Add omega 3 fatty acids

Similar to carotenes, omega 3 fatty acids are suggested as being supportive in the prevention of ARMD and should be included in the diets of all ages.

Lastly, due to the fact that there are other factors which are not modifiable and may lead to the development of ARMD, it is always best to screen and initiate treatment as early as possible in order to prevent progression of the disease and to avoid the occurrence of complete blindness.

Limited Retinal Translocation for Wet Macular Degeneration

2010-09-01T18:35:00.000-07:00

by Samantha Power

August 31st, 2010

Limited Retinal Translocation-Limited retinal translocation is another treatment aimed at wet macular degeneration. In this procedure the retina is actually moved somewhat to allow laser treatments to be applied more successfully to abnormal blood vessel growth. The procedure is still in the macular degeneration treatments developmental stages in terms of approval for commercial applications. Surgical options for dry macular degeneration are proposed periodically. The methodologies change from procedure to procedure, but the general idea is the same.

Macular Degeneration Surgery

2010-08-23T06:46:00.000-07:00

By Joven Villanueva

While the quest in searching for the cure of macular degeneration is on going. Many national eye centers are investigating new ways to treat the said illness. There are different options in managing macular degeneration as the illness has two types. The wet form which usually results to loss of vision due to no reliable treatment yet to be developed and the dry form accounting 90% of cases can still be managed and controlled if diagnosed at an early stage and by eating the right food rich in vitamins A, C, E and other supplements such as zeaxanthine and zinc - proven to be effective in slowing down the disease

Here are some optional treatments available for patients having the wet form of macular degeneration. First is Photodynamic therapy which uses a combination of both cold laser and light-sensitive drug destroying abnormal blood vessels as the drug travels to the unwanted vessels after it was injected from the arm. Another option is Laser therapy where high energy lights are used to destroy abnormal growing blood vessels.

The Cole eye institute is conducting experimental treatments such as a surgery to remove abnormal blood vessels and blood. A genetically engineered enzyme is used by the surgeon to dissolve blood clots under the macula. Another procedure is called Macular translocation.This is performed using a laser therapy to treat abnormal blood vessel. To prevent the formation of scar tissue and damage to retina, the surgeon rotates the retina in a healthy area.

The healing process may take three to six weeks. The doctor may request for an angiogram after the macular surgery to make sure that there are no additional blood leakage in the area. An additional laser treatment maybe performed if a problem was observed.

Macular degeneration is a medical condition resulting to loss of vision making it difficult to read and recognize faces. To better understand the patient's condition, print out some letters six inches high and try to identify them while looking it at straight ahead. Hold the paper slightly to the side. This visual impairment does not lead to total blindness and in most cases some vision remains.

This disease mostly affects older and adults 50 years old and above. In a recent study for macular degeneration it was found out that those patients aging sixty six to seventy four suffer from this illness. Mostly women are prone to macular degeneration compare to men and smokers of any gender are also part of the growing list as tobacco increase the risk in three folds due to the toxic effects in retina. It is even 50% risky for those who have relatives with muscular degeneration to develop the illness compare to those who doesn't have with only 12% probability. Caucasians are more prone to develop macular degeneration compare to other races.

Other than age and family history, there are factors that cause macular degeneration. These includes hypertension or commonly known as high blood pressure, obesity, and high fat intake.

Ophthalmologists diagnose macular degeneration by looking at the abnormal vessels under the retina. A dye is injected in the arm of the patient where pictures are taken by a special camera until it reaches the eye. Any changes in the retina as shown from the photographs taken will serve as a guide for treatment.

Epidemiolgy and Burden of Retina Disease

2010-08-18T07:37:00.000-07:00

By Nancy M. Holekamp, MD

Age-related macular degeneration. The Eye Disease Prevalence Group has estimated that 1.75 million people in the United States have advanced age-related macular degeneration (AMD), including neovascular AMD or geographic atrophy, but not necessarily involving the foveal center, with the highest prevalence in adults older than 80 years of age.1 These numbers are estimated to increase substantially in the coming decades.

The numbers are huge, but what impact does AMD have on our patients? AMD is associated with an increased incidence of depression, mortality, and a greater need for assistance for daily tasks. In a quality-oflife study that was part of the Submacular Surgery Trials (SSTs), patients were asked to rate their current vision during phone interviews. Patient scores were converted to a preference value scale ranging from 1 (perfect health with perfect vision) to 0 (death). A mean preference value of 0.64 for subfoveal choroidal neovascularization (CNV) suggests a profound impact on quality of life. The impact is reported as greatest in those with the most severe loss of vision, but even patients with visual acuity of at least 20/40 in one eye had relatively low preference values.2 This is striking because it is right between having chronic renal failure and symptomatic HIV/AIDS (Figure 1). Clearly, AMD has a significant impact on the quality of life of individuals.

Diabetic retinopathy. It is well known that we are in the midst of an epidemic of obesity and diabetes in the United States. The rates of both have increased dramatically from 1990 to 2001, particularly in the southeast (Figure 2) and the increase in people with diabetes directly correlates to the rise in obesity.3 An estimated 18.2 million people had diabetes in the United States in 20023 and diabetes has been estimated to affect 151 million people worldwide, and is projected to increase to 324 million by 2025.4 It is also estimated that 35% of any diabetic population will have diabetic retinopathy.5 We know this from the Beaver Dam Eye Study. In terms of costs, the direct and indirect costs for diabetes were estimated at $132 billion in 2002.6 Almost $1 out of every $5 in the United States spent on healthcare is for patients with diabetes. Diabetes has an enormous impact on patients’ quality of life and represents a large economic issue.

Retinal vein occlusion. Retinal vein occlusion (RVO) is the second most common retinal disease after diabetic retinopathy. The Beaver Dam Study reported a prevalence of 0.6% in patients older than 43 years and the same study reported a 15-year cumulative incidence of BRVO of 1.8%.7 Although these numbers may sound low, the average age of these patients is 65 and this age group may have a host of comorbidities (eg, hypertension, vascular disease, diabetes). RVOs share risk factors with myocardial infarction (MI),8 stroke, and other arterial thrombotic events.9 In a study that is currently in press,10 we reviewed the records of 4,500 patients with RVO and compared them with 13,500 patients who were age-matched controls. We found that patients with RVO had significantly higher likelihood of having angina, cardiac arrhythmia, congestive heart failure, diabetes, heart disease, MI or stroke, hyperlipidemia, and hypertension (P=.001) The incidence of RVOs continues to increase as the incidence of diabetes increases and the population ages.

EVIDENCE-BASED MEDICINE
Evidence-based medicine is the practice of medicine based on the best scientific data available. The questions are, “How much evidence do you need?” and “How much science is behind it?”

These are the various levels of evidence. The weakest is the single-case report, which is level 5 evidence. The second weakest is the case series without a comparison group (level 4). Level 3 evidence consists of nonrandomized clinical trials that may compare two groups that are not concurrent or randomized. A level 2 clinical trial is similar to a phase 2 US Food and Drug Administration (FDA) clinical trial—it is randomized and controlled but it has a high type-1 error, where a trend is apparent and may be significant, but the number of patients is insufficient. A type-2 error is when a treatment difference likely exists but, again, there are not enough patients to isolate the difference.

Level 1 evidence is from randomized, prospective, controlled trials, with a low type-1 and type-2 errors. These are the phase 3 clinical trials that eventually lead to drug approval by the FDA. The key to level 1 evidence is a well-designed study and a large number of patients.

CLINICAL TRIAL DESIGN: WHY IS IT IMPORTANT?
In medicine we prefer level 1 trials because of random assignment to treatment or control; the concurrent enrollment that ensures patients are being treated in a similar manner; the large numbers of patients; and the masking of the investigators. The standardized follow up is also important to the significance of outcomes. By controlling these variables, we are able to clinically treat patients in the most scientific manner. My colleague Kuldev Singh, MD, who is a glaucoma specialist has said, “This term [randomized, controlled] allows the investigator to disarm the novice scientific critic, while impugning lesser prospective and all retrospective studies, not to mention case series and reports.” The randomized, controlled study is at the top of the food chain.

A case example of using low-level evidence-based medicine upon which to base treatment decisions is that of bevacizumab (Avastin, Genentech) for treating AMD. In August 2005, there was one case report (level 5 evidence) demonstrating improvement on optical coherence tomography (OCT) for a patient nonresponsive to pegaptanib sodium (Macugen, Eyetech/Pfizer) for AMD in the published literature.11 Simultaneously, Philip Rosenfeld, MD, PhD, one of the authors of the aforementioned case report, presented a paper (level 4 evidence) at the American Society of Retina Specialists in Montreal on a series of patients with exudative AMD who benefited from intravitreal bevacizumab. Clearly, the “bevacizumab for AMD” era was ushered in using the least convincing type of evidence.

Unlike bevacizumab, ranibizumab (Lucentis, Genentech) was subject to two phase 3 randomized, controlled clinical trials sponsored by industry (MARINA ANCHOR) that resulted in FDA approval. The extent to which the efficacy and safety of ranibizumab has been scrutinized is to the highest level.

But can you have a randomized, controlled trial for every disease and treatment? Paul Lichter, MD, said, “Authors of case reports, retrospective studies, and other manuscripts covering the gamut of imperfect clinical projects often conclude their papers by calling for a randomized, controlled, collaborative clinical trial. While I have no idea how many times such statements are made, there is no question that these pronouncements are abundantly more frequent then the clinical trials that result from them.”

CRITERIA FOR CONDUCTING A LEVEL 1 CLINICAL TRIAL
Clearly, a level 1 clinical trial cannot be conducted for every clinical situation. My four criteria for conducting a randomized, controlled clinical trial include the following:

* The disease must represent a significant health problem. An example of what can be called an questionable effort is in 1993 when the Canadian Ophthalmology Study Group conducted a multicenter randomized, controlled clinical trial to compare the argon green vs krypton red laser for choroidal neovascularization (CNV) in AMD.12 The comparison of these lasers was not a burning issue for the health care system.
* There must be scientific plausibility of benefit. In other words, there has to be some biologic basis for believing that a treatment works. An example from the AMD literature is subfoveal laser for CNV.13 There was no basis to suggest that applying laser to a patient’s fovea would be beneficial.
* A plausible, biologic benefit must exist. In other words, the early data on a new treatment should suggest the possibility of benefit. A good example of this is the Submacular Surgery Trials in AMD where early pilot data did not show any benefit to submacular surgery over laser photocoagulation.14 The eventual the long-term data supported this conclusion.
* Sufficient numbers of patients must be enrolled. If a study cannot recruit enough patients, it will not succeed. For example, it was almost impossible to recruit patients into the Macular Translocation clinical trial because they were randomized to either photodynamic therapy—a relatively painless 15-minute office-based laser procedure— or to macular translocation, which had a 25% complication rate at the time they were trying to enroll.15

The clinical trials’ registry, www.clinicaltrials.gov, currently lists 530 clinical trials for the treatment of AMD. Of those 200 trials are open and actively recruiting patients. Eighty-seven of these are randomized and controlled. Those of us in the field of ophthalmology and the subspecialty of retina are fortunate to be part of a profession that is committed to providing the best scientific evidence for its members. We have a long, proud history of practicing evidence-based medicine and performing randomized clinical trials in our field.

NON-INFERIOR CLINICAL TRIALS
There are basically three types of trial design: superiority, equivalence, and non-inferiority. The Comparisons of Age- Related Macular Degeneration Treatments Trials (CATT) is a non-inferiority trial comparing intravitreal ranibizumab to intravitreal bevacizumab. The margin of non-inferiority must be pre-specified in the design protocol to construct a two-sided, 95% confidence interval (CI) to determine the true difference between the agents. To be able to declare bevacizumab non-inferior, that interval must lay entirely on the positive side of the non-inferior margin.

Figure 3 helps illustrate how the results of a non-inferiority trial are interpreted. Applied to the CATT, if proved non-inferior, bevacizumab is either almost as good as, equivalent to, or better than ranibizumab. If bevacizumab fails non-inferiority then it is either equivalent, almost as good as, or inferior to ranibizumab. All of those possibilities exist.

The major criteria for non-inferiority clinical trials are:

1) historical evidence that the reference drug works (ie, MARINA and ANCHOR);

2) trial design must be the same as the reference trial (ie, the CATT has same design as MARINA and ANCHOR);

3) trial conduct must be the same (ie, many of the clinical sites from MARINA and ANCHOR are also sites for the CATT);

4) the non-inferior margin (minus delta) must be acceptable (ie, six letters for the CATT).

In addition to the CATT, there are two other non-inferiority trials in AMD: HARBOR (A Study of Ranibizumab Administered Monthly or on an As-Needed Basis in Patients With Subfoveal Neovascular Age-Related Macular Degeneration) and VIEW I (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD). These are both similar to MARINA and ANCHOR in historical evidence, trial design and trial conduct, and have an acceptable non-inferior margin.

SUMMARY
The best way to practice evidence-based medicine is with phase 3, randomized, and controlled trials. The requirements for level 1 clinical trials do not necessarily constitute a “cookbook” for successful trials; rather, they provide guidelines for those who are designing and participating in clinical trials.

Finally, evidence alone is never sufficient information to make a clinical decision—there are many factors to be taken under consideration. When treating our patients, we consider several factors including a patient’s values, socio-economic status, and age; however we should rely on three main components: our years of clinical experience, the patient’s particular circumstances, and what we have learned from evidence-based medicine.

1. Friedman DS, O’Colmain BJ, Muñoz B, et al; The Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Archives of Ophthalmology. 2004;122:564-572.
2. No authors listed. Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: II. Quality of life outcomes submacular surgery trials pilot study report number 2. Am J Ophthalmol. 2000;130(4):408-418.
3. National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics Fact Sheet: General Information and National Estimates on Diabetes in the United States. Bethesda, MD, US Department of Health and Human Services, National Institutes of Health, 2003.
4. King H, Rewers M. Global estimates for prevalence of diabetes mellitus and impaired glucose tolerance in adults: WHO Ad Hoc Diabetes Reporting Group. Diabetes Care. 1993;16:157–177.
5. Beaver Dam Eye Study.
6. Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003;26(3):917-932.
7. Klein R, Klein BE, Moss SE, Linton KL. Beaver Dam Eye Study. Retinopathy in adults with newly discovered and previously diagnosed diabetes mellitus. Ophthalmology. 1992;99(1):58-62.
8. National Heart Lung and Blood Institute. Heart attack. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/HeartAttack/HeartAttack_WhatIs.html.
9. Thom T, Haase N, Rosamond W, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Committee. Circulation. 2006;113:85-151.
10. Holekamp N. Arch Ophthalmol. In press.
11. Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005;36(4):331-335.
12. The Canadian Ophthalmology Study Group. Argon green vs krypton red laser photocoagulation of extrafoveal choroidal neovascular lesions. One-year results in age-related macular degeneration. Arch Ophthalmol. 1993;111:181-185.
13. Macular Photocoagulation Study Group. Visual outcome after laser photo- coagulation for subfoveal neovascularization secondary to age-related macular degeneration. The influence of initial lesion size and initial visual acuity. Arch Ophthalmol. 1994;112:480–488.
14. Bressler NM, Bressler SB, Hawkins BS, Marsh MJ, Sternberg P Jr, Thomas MA; Submacular Surgery Trials Pilot Study Investigators. Submacular surgery trials randomized pilot trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes submacular surgery trials pilot study report number 1. Am J Ophthalmol. 2000;130(4):387-407.
15. Hawkins BS, Bressler NM, Miskala PH, et al; Submacular Surgery Trials (SST) Research Group. Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: ophthalmic findings: SST report no. 11. Ophthalmology. 2004;111(11):1967-1980.

Retinitis pigmentosa treatment

2010-08-09T06:18:00.000-07:00

As human beings, there is very little more universally feared than the dark, and few disabilities more frightening than blindness which would leave us trapped in it. Retinitis pigmentosa is a condition which, to many people, might sound like a nightmare. Retinitis pigmentosa refers to a group of genetic conditions in which the eye progressively degenerates over time. The first symptoms of retinitis pigmentosa are night blindness. This night blindness worsens over time, eventually developing into tunnel vision which little by little narrows the sufferer’s peripheral vision until finally they become legally – and perhaps totally – blind.

Progression is different in each case of retinitis pigmentosa. The night blindness phase of the disease can proceed tunnel vision by years or even decades, and many people with retinitis pigmentosa do not legally go blind until their forties or fifties. Some never retain some level of vision throughout their lives. At the same time, others may go blind as early as during childhood.

Retinitis pigmentosa diagnosis come as a fearful shock to some people, which is why retinitis pigmentosa treatments are so important.

Since time out of mind, people have struggled to treat the diseases around them. They have relied on everything from superstition, prayer, spells and religious chants to herbal remedies, surgeries and medicines, some of which are still in use today. Unfortunately for people before the modern era, there was very little to be done for loss of sight. Our ancestors had very few options in terms of treatment for retinitis pigmentosa. Retinitis pigmentosa is caused by abnormalities in the receptors in the eye, the rods and cones which allow us to see color, light and movement. As these abnormalities increase over time, the sufferer’s eyesight diminishes. There was very little for even our grandfathers and grandmothers to do when faced with this sort of disease. It has only been recently that our understanding of how the eye works, our understanding of how the body as a whole operates, and our technology has reached a point where retinitis pigmentosa treatments have become something of a reality and moved out of the realms of witchcraft and hope.

Retinitis pigmentosa treatments are still relatively few. There is no true cure for retinitis pigmentosa, only treatments which may help to slow the progression of this degenerative disease.

Among the first treatment options for people diagnosed with retinitis pigmentosa are medications and supplements. For example, vitamin A therapies can support eye health and slow the progression of this disease. People who receive these should have their liver enzymes checked annually, since in too great of doses, vitamin A can become toxic to the system. Other retinitis pigmentosa treatment options include omega-3 polyunsaturated fatty acid and antioxidant, docosahexaenoic acid, acetazolamide, lutein, and calcium blockers.

In the event that medication proves an ineffective retinitis pigmentosa treatment, there are also surgical treatments to consider. What kind of surgical options a patient may have for their retinitis pigmentosa treatment depends on many factors, as the progression of the disease varies greatly from person to person, and as the disease is associated with a number of other genetic and structural conditions. For some people, partial retinal transplants can be a useful retinitis pigmentosa treatment. The possibility of a retinal prosthetics
have also been under consideration for several years now. While there are currently no prosthetics available for clinical use as retinitis pigmentosa treatment, they may present a promising future for those with this degenerative disease.

Since retinitis pigmentosa is a genetic disorder, it should not be surprising that when considering retinitis pigmentosa treatments, speculation might turn to the possibilities of gene therapy and stem cell research. These treatments are, as yet, still in the research and investigation phases, but may well represent the future of retinitis pigmentosa treatment.

Commencement of CABERNET clinical trial

2010-07-26T09:46:00.000-07:00

NeoVista, Inc announced the official commencement of the CABERNET (Cnv Secondary Amd Treated with BEta RadiatioN Epiretinal Therapy) clinical trial for the treatment of subfoveal choroidal neovascularization associated with wet age-related macular degeneration (AMD). Neovascular AMD is the leading cause of irreparable blindness in the elderly population, afflicting over 200,000 individuals each year in the U.S.

Dr. Nelson Sabates, Professor and Chairman, Department of Ophthalmology, University of Missouri-Kansas City (UMKC)/Truman Medical Centers and Director of Vision Research Center, University of Missouri-Kansas City at Truman Medical Centers performed the procedure on the first patient enrolled in the CABERNET study. When asked for initial feedback on the procedure, Dr. Sabates commented, "The procedure was no different than performing a common vitrectomy and the Epi-Rad device allowed me to deliver a well focused dose of radiation to the lesion. Treating neovascular AMD using a multi-faceted approach like the use of radiation and anti-VEGF therapy may well be the next frontier in combating this sight threatening disease."

The CABERNET clinical trial will involve clinical sites in the United States, Europe, Israel, and South America. The CABERNET trial protocol is divided into two treatment arms - investigational and control.

The investigational treatment arm consists of concomitant delivery of Beta radiation, via the proprietary NeoVista technology (Epi-Rad90™), and an FDA approved anti-VEGF agent. The investigational treatment is administered during an outpatient surgical procedure and delivers Beta radiation directly to the area of the retina that has been compromised by the disease. An injection of the anti-VEGF agent is administered at the time of surgery with one additional injection administered 30 days after surgery. The control arm is utilizing the FDA approved anti-VEGF agent alone.

The surgery was performed in collaboration with, Saint Lukes Hospital in Kansas City. Dr. Terry J. Wall, J.D., M.D. of the Saint Lukes Cancer Institute was the attending radiation oncologist involved with the procedure.

"This is a very good day for NeoVista employees and the investors who are supporting our work," stated John N. Hendrick, President and CEO of NeoVista. "More importantly, it is a potential harbinger of hope for those suffering from wet AMD." We remain optimistic that our treatment approach will provide maximum benefit to this patient population."

Treatment for Cataracts/ other eye diseases

2010-07-26T06:48:00.000-07:00

What is a cataract?

There is only one known treatment for cataracts - surgery! A cataract needs to be removed only when vision loss interferes with your everyday activities, or the things you like to do such as driving, reading, sewing, playing golf or watching TV . You and your eye care professional can make this decision together. Once you understand the benefits and risks of surgery, you can make an informed decision about whether cataract surgery is right for you. In most cases, delaying cataract surgery will not cause long-term damage to your eye or make the surgery more difficult. You do not have to rush into surgery.

Additionally, Medicare and most commercial insurance carriers require that best corrected vision be reduced to some level (often 20/50 visual acuity) before they will approve the surgery for payment.

Sometimes a cataract should be removed even if it does not cause problems with your vision. For example, a cataract should be removed if it prevents examination or treatment of another eye problem, such as age-related macular degeneration or diabetic retinopathy.

If you choose surgery, your optometrist will refer you to an ophthalmic surgeon to remove the cataract. This is a very definite advantage over choosing an eye surgeon out of the phone book or from your friends because your doctor knows firsthand the quality of the cataract surgery performed by local eye surgeons. Because they work with the eye surgeons and usually perform some or all of the post-op care they truly know where to refer you for the best possible outcome. If you have cataracts in both eyes that require surgery, the surgery will be performed on each eye at separate times, usually four to eight weeks apart.

As with any surgery, cataract surgery poses risks, such as infection and bleeding. Before cataract surgery, your doctor may ask you to temporarily stop taking certain medications that increase the risk of bleeding during surgery. After surgery, you must keep your eye clean, wash your hands before touching your eye, and use the prescribed medications to help minimize the risk of infection. Serious infection can result in loss of vision. Talk to your eye care professional about these risks. Make sure cataract surgery is right for you.

Cataract surgery slightly increases your risk of retinal detachment. Other eye disorders, such as high myopia (nearsightedness), can further increase your risk of retinal detachment after cataract surgery. One sign of a retinal detachment is a sudden increase in flashes or floaters. Floaters are little "cobwebs" or specks that seem to float about in your field of vision. If you notice a sudden increase in floaters or flashes, see an eye care professional immediately. A retinal detachment is a medical emergency. If necessary, go to an emergency service or hospital. Your eye should be examined by a retinal specialist as soon as possible. A retinal detachment causes no pain. Early treatment for retinal detachment often can prevent permanent loss of vision. The longer the retina stays detached, the less likely you will regain good vision once you are treated. Even if you are treated promptly, some vision may be lost.

Foveal Macular Edema Treatments

2010-07-19T07:19:00.000-07:00

Located in the foveal region of the retina, the macula is an important part of the visual system, responsible for clear central vision. A damaged macula means distorted vision when looking at objects straight ahead. Macular edema, one type of damage, occurs when fluid accumulates in the tissue under the macula. Causes of edema include ocular inflammation and, more commonly, complications from uncontrolled diabetes. Prompt treatment is crucial to preserving vision when macular edema occurs.

Laser Treatment
According to the Mayo Clinic, macular edema is the leading cause of decreased vision in patients with early diabetic eye complications, also called background diabetic retinopathy. Uncontrolled diabetes leads to leakage of blood vessels in the back of the eye. Fluids, such as blood and fatty lipid material called exudates, can then accumulate. This can lead to numerous complications, including swelling under the macula tissue. When this occurs, clinically significant macula edema requires treatment with a focal laser procedure, also called focal laser photocoagulation. Laser light focused on the macula targets the leaky vessels, resulting in laser scars or burns that help reduce further leakage and the amount of fluid accumulated. If laser treatment for both eyes is necessary, the treatments are usually scheduled a few weeks apart. Focal laser photocoagulation is the mainstay treatment for macular edema caused by diabetic retinopathy and, according to the National Eye Institute, reduces the chance for vision loss by 50 percent.

Anti-inflammatory Drugs
Macular edema can result from retinal inflammation. It often follows procedures such as cataract surgery. In this type of edema, cyst-like pockets of fluid build up in the macular region--hence its name cystoid macular edema--and the reason for its development is unknown. Often, steroidal anti-inflammatory eyedrops are prescribed to treat cystoid macular edema. An injection of steroids--such as cortisone--into the eye can be necessary in cases of more severe edema. According to the University of Michigan, injecting steroids intraocularly for macular edema caused by diabetes is an emerging treatment option. Repeat injections are often necessary.

Vitrectomy
The vitreous is the large, gel-like area that makes up a bulk of the back of the eye. It comes in contact with the retina and macular tissue. Sometimes tugging of the macula by the vitreous gel can lead to macular edema. When this occurs, it's recommended to have surgery to remove the vitreous gel. This procedure is called a vitrectomy. A vitrectomy is also performed when macular edema and other complications caused by diabetes result in significant blood accumulation in the vitreous. This procedure is usually recommended for advanced diabetic cases.

Preventive Care
The most serious type of macular edema is connected to diabetic retinopathy, because there is a high risk for vision loss. Therefore, doctors strongly recommend control and care of blood sugar through diet, exercise and medication. Other preventive measures include annual eye exams and controlling other diseases such as high blood pressure and high cholesterol. The National Eye Institute reports that macula edema can often occur without symptoms of blur, so preventive care is essential to detecting it before lasting damage can occur.

Gene Therapy for Eye Diseases

2010-07-16T07:19:00.000-07:00

The pharmaceutical giant Genzyme has started a clinical trial to see whether a drug to treat macular generation could be delivered via long-lasting gene therapy rather than monthly injections.

Eye colors: Drusen, the yellow flecks in this image of the retina, are common in people with age-related macular degeneration. These flecks are made up of proteins involved in the part of the immune system called the complement system, which has also been implicated in the disease by genetic studies.

A drug called Lucentis, made by Genetech, has proved effective at treating the wet form of age-related macular degeneration, which can lead to blindness. Some 200,000 Americans a year are diagnosed with the disease. But Lucentis has to be injected into the eye every month or two, a burden for patients and doctors.
Lucentis binds to and neutralizes a wound-healing growth factor known as VEGF. This binding action stalls the excess growth of blood vessels in the eye that characterizes age-related macular degeneration. Genzyme's gene therapy drug, officially called AAV2-sFLT01, would insinuate itself into the patient's retinal cell to produce the same VEGF-binding protein as Lucentis over far longer periods--up to several years.

A phase 1 clinical trial of Genzyme's gene therapy treatment began at the end of May. Three patients received the treatment, according to Sam Wadsworth, a Genzyme group vice president in charge of gene and cell therapy. Preliminary results should be available in about a year.

The trial is one of a handful worldwide seeking to prove the effectiveness of gene therapy for eye diseases. The Genzyme trial also involves using new type of virus as the delivery mechanism. Early results of a federally funded trial to deliver normal-functioning genes to patients with a rare retinal disease known as type 2 leber congenital amaurosis, or LCA, have confirmed that this "viral vector" has merit for eye treatments, several researchers say.

The LCA trials "demonstrated success both in terms of safety and ability to introduce the gene and have efficacy and success," said Jeffrey S. Heier, an assistant professor at Tufts University School of Medicine and director of retinal research at Ophthalmic Consultants of Boston, a private practice group, who is involved in the Genzyme research. "This study is taking the virus vector that they used, and [Genzyme has] taken what has really been the success of the anti-VEGF story and they've packaged the two together."

Eyes have been an early target for gene therapy because they are small--meaning they require relatively little active dose, they are self-contained, and because the tools of eye surgery have advanced enough to make the treatments possible. The drug has to be delivered to the retina, a thin film lining the inner wall of the eye. Instrumentation has improved in recent years to allow injections through the retina without piercing it, said Shalesh Kaushal, chairman of ophthalmology at University of Massachusetts Memorial Medical Center and UMass Medical School.

To Kaushal, who is involved in the Genzyme study as well as the LCA research, the big challenge will be broadening the use of gene therapy to dozens more diseases, and using that understanding to eventually reach beyond the eye. "If one could understand those fundamental cellular, biochemical events and identify targets, you might have the chance to treat many diseases with a single gene-therapy construct," Kaushal said.

Earlier gene therapy programs used a type of virus called adenovirus to target genes, but both the LCA and Genzyme trials are using adeno-associated virus, which is far less inflammatory and which expresses itself over longer periods than adenovirus, therefore making the treatment last longer, Wadsworth said. Viruses are used to deliver gene therapies because they are adept at getting through cell walls.

VEGF is involved in vascular cell growth throughout the body, and its expression increases in the presence of a wound. Studies have shown that with Lucentis, virtually all the VEGF-binding protein stays within the eye, and does not significantly affect VEGF levels elsewhere in the body, Wadsworth says. Genzyme's drug will provide even lower levels of the VEGF-binding protein, so it's expected that the drug will not have any adverse affects throughout the body, he said.

The trick will be getting the cells to produce enough VEGF-binding protein to help patients, said Peter Campochiaro, a professor at the Wilmer Eye Institute at Johns Hopkins Medicine, who is involved in the research. In addition to establishing safety, the current phase 1 trial will explore four different doses of the study

Tyrosine Kinase inhibitor shows promise for AMD treatment

2010-07-07T04:16:00.000-07:00

A new study finds that inhibition of CXCR4 may be useful in preventing neovascularization but does not appear to have an effect on already established angiogenesis, whereas a multiple receptor tyrosine kinase inhibitor (SU14813) reduced the size of previously formed lesions.

Endothelial precursor cells (EPCs) derived from hematopoietic stem cells (HSCs) have been shown to contribute to choroidal neovascularization (CNV) by signaling through the SDF-1 and its receptor, known as CXCR4. Hematopoietic stem cells are implicated in the formation of new pathologic vessels observed in wet AMD. Recruitment of endothelial precursor cells to the site of neovascularization is mediated, in part, by the chemokine SDF-1, and its receptor, CXCR4. CXCR4 is a G-protein-coupled receptor found on lymphocytes, monocytes, hematopoietic, endothelial progenitor cells, and mature endothelial cells.

Methods and Results

CNV in rats was generated by focal rupture of Bruch's membrane with an 810-nm diode laser. In the prevention mode, a CXCR4 antagonist (AMD3100) was delivered via an osmotic pump 1 day after laser induction. In the intervention mode, AMD3100 delivery commenced 14 days after laser induction. Inhibition of CXCR4 was determined through leukocyte and SDF-1 actin polymerization blood biomarker assays. Leakage was assessed by fluorescein angiography, and CNV lesion size was quantified after isolectin B4 endothelial cell staining. SU14813, an anti-VEGFR, PDGFR-beta, KIT, and FLT3 inhibitor, was also assessed in an intervention study protocol.

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Inhibition of CXCR4 was demonstrated by an increase in the number of blood leukocytes, and diminished SDF-1 induced actin polymerization in whole blood. CNV leakage and neovascularization were inhibited when the dose regimen was initiated 1 day after laser-induced CNV induction. AMD3100 did not show efficacy when administered 14 days after lasering. Treatment with SU14813 significantly decreased CNV leakage and lesion size in an intervention modality.

Discussion and Conclusions

In this study, CXCR4 inhibition was efficacious in the prevention of CNV, but failed to reduce choroidal leakage and angiogenesis in the intervention modality. This finding suggests that therapies targeting the SDF-1/CXCR4 axis may be beneficial in blocking the induction of ocular neoangiogenesis, but are unlikely to reduce already established angiogenesis.

There is strong evidence that CXCR4 inhibition disrupts the recruitment of endothelial precursor cells (EPCs) to sites of angiogenesis, most likely the major mechanism leading to efficacy in the prevention model.

In addition to suppressing CNV, CXCR4 inhibition reduced choroidal vascular leakage in the prevention modality (but not in the intervention modality). It is not known whether CXCR4 inhibition decreases leakage directly or as a secondary effect of the reduction of the angiogenic vessel area.

The observation that CXCR4 inhibition did not decrease choroidal leakage or angiogenic lesion size in the intervention modality suggests that after a 2-week generation of laser-induced CNV, there is limited, if any, contribution of EPC cells to the already established vessels

A multiple receptor tyrosine kinase (RTK) inhibitor may still be an effective monotherapy, as SU14813 reduced the size of previously formed lesions. In treatment mode, both leakage and angiogenesis decreased even after the pathologic effect was given 14 days to fully establish before drug intervention. This study suggests that blockade of the VEGF receptor is an effective alternative method of inhibiting the VEGF pathway compared to conventional anti-VEGF strategies.

SU14813 is a small molecule with broad target RTK selectivity, inhibiting the VEGF receptor (VEGFR), PDGFR-β, KIT, and FLT3. Although the primary mechanism that reduces preexisting angiogenesis and leakage is the blockade of the central VEGF pathway, the additional inhibition of PDGFR-β may augment efficacy in this model over single anti-VEGFR agents.

The investigators conclude that inhibition of CXCR4 may be useful in preventing neovascularization but does not appear to have an effect on already established angiogenesis. A multiple receptor tyrosine kinase inhibitor (SU14813) approach shows promise for the treatment of wet age-related macular degeneration.

Finding Macular Degeneration Treatments

2010-06-30T09:38:00.000-07:00

Finding macular degeneration treatment s. Vision problems due to the onset of macular degeneration are quite prevalent, especially in the elderly. Macular degeneration occurs when the macula, located in the central portion of the retina in the eye, becomes weakened or damaged. The result is a loss of central vision. Central vision is used to read and drive, so it is crucial to save as much of a patient’s vision as possible as soon as possible. Although this medical condition has no cure at this time, there are some promising new macular degeneration treatments that have shown to alleviate and slow down some of the symptoms of age-related macular degeneration.

There is a range of vision loss that can occur depending on the severity and type of age-related macular degeneration a patient has. Because it affects the macula located in the center of the retina, a patient’s peripheral vision is usually not adversely affected by the condition. With the onset of the condition, a patient’s vision might still be quite good, but the situation can worsen over time. There are two different types of age-related macular degeneration that often result in the greatest loss of central vision, and they are called wet and dry. The dry form of advanced macular degeneration is caused by the reduction of the rods and cones located in the retina, while wet advanced macular degeneration occurs due to leakage of excessive blood vessels and the resulting scarring under the macula.

One thing that retinal specialists might tell their patients with macular degeneration is to take certain vitamins as part of a spectrum of macular degeneration treatment s. Patients in the initial onset stages of this condition sometimes benefit from taking vitamins C, E, zinc, lutein, zeaxanthin and eating foods that are high in beta-carotenes, such as dark green leafy vegetables, corn and peas.

Another macular degeneration treatment can be found in cholesterol reducing drugs. People in the early stages of this medical condition often develop drusen, or yellow deposits, in the macula. The development and increase in the number of drusen seems to be related to the patient’s cholesterol level, with drusen more prevalent in those with higher cholesterol. Medications, such as statins, which reduce cholesterol, and aspirin, which reduces inflammation, may have a significant impact on reducing the size and number of drusen in the macula and thus lessen the chances of someone developing age-related macular degeneration.

A couple of wet advanced macular degeneration treatments, Macugen and Lucentis, have been approved by the FDA. Macugen is useful because it helps to reduce the number of excessive blood vessels that can grow under the retina. These can become inflamed and eventually burst, causing vision problems. Lucentis also reduces the growth of too many blood vessels. Lucentis is administered as an injection under the eye, and offers a great new treatment option for some patients with these kinds of vision problems.

The future is looking brighter with these emerging new macular degeneration treatments.

Susan Slobac has had a parent diagnosed with macular degeneration. She has had experience in macular degeneration treatment. In this article, she discusses macular degeneration risk factors.

For more information follow us at www.maculardegenerationassociation.org

Wider access to drug to prevent and reverse eye damage

2010-06-10T07:05:00.000-07:00

By: Staff Writer

Manitobans now have wider access to a drug to prevent and reverse eye damage, Health Minister Theresa Oswald said Wednesday.

The drug Lucentis is now available through doctors' offices to treat wet macular degeneration.

Last March the province said Manitoba Health would cover Lucentis treatment though the Misericordia Eye Centre of Excellence as of June 1.

At that time the province said it wanted to expand patient access to Lucentis through other retinal specialists' offices.

Oswald said Lucentis is now accessible through doctors' offices ahead of schedule.

Wet macular degeneration is a disease that can impair vision and cause blindness.

Lucentis has been available at no cost to Manitobans with wet macular degeneration since June 1 through the Misericordia and Manitoba retinal specialists.

Manitoba Health says up to 1,000 patients could benefit from this new program annually.

Dampening a light-sensing reaction in the eye might slow a common cause of blindness

2010-06-02T14:11:00.001-07:00

MIT Technology Review, by Emily Singer - Molecules designed to slow the production of toxic byproducts in the eye by making it less sensitive to light are now being tested in patients with macular degeneration, the leading cause of blindness in people age 50 and older. If successful, the compounds would provide a much needed therapy for the disease, which affects more than 15 million people in the United States.

In macular degeneration, cells in the center of the eye, called the macula, deteriorate. A handful of new treatments for the more severe form of the disease, known as wet AMD, have been approved in recent years. But no treatments are yet available for the dry form, which accounts for about 90 percent of cases. Some dry cases ultimately progress to the wet form, which accounts for a large part of AMD-related blindness. “If you can treat dry AMD, you can kill two birds with one stone,” both reducing early symptoms and preventing progression to the wet form, says Paul Sieving, director of the National Eye Institute, in Bethesda, MD.

While scientists are still trying to understand the causes of AMD–age is the biggest risk factor, with genetics and lifestyle factors also playing a role–a growing pool of evidence suggests that the build up of specific compounds in the eye can hasten the cellular damage that underlies the disease. These compounds accumulate in the photoreceptors–cells in the retina that detect light–during normal eye function as the light-sensitive pigments in these cells change conformation in response to photons.

One form of the photopigment, a derivative of vitamin A, is highly reactive and leaks into nearby tissue called the retinal pigment epithelium. “Over time we think these compounds are a burden for the retinal pigment epithelium, which is essential for the healthy function of the photoreceptors,” says Janet Sparrow, director of the Retinal Cell Biology Laboratory at Columbia University, in New York. “In age-related macular degeneration, particularly the dry form, these cells die, and the photoreceptors follow.”

While this reaction is vital for sight, researchers believe that slowing the cycle in the subset of photoreceptors responsible for night vision, known as rods, could slow damage without having a large impact on daytime vision. (Preliminary results suggest it can affect dark-adaptation–when our eyes adjust to low-light conditions.) “During the daytime, the rods are spinning like crazy, wasting vitamin A for no good use,” says Ryo Kubota, an ophthalmologist and founder of Acucela, a Seattle-based startup that is developing treatments for macular degeneration. “It’s like a CCD camera pointed at the sun.”

One compound developed by Acucela that is in clinical trials inhibits the enzyme that converts the photopigment in photoreceptors from one form to another. This process happens only in the eye, allowing the drug to be administered systemically without affecting other tissue, says Kubota. The company has finished initial safety testing in humans and plans to begin a clinical trial assessing the compound’s effectiveness in patients with late-stage dry macular degeneration in a few weeks. Kubota also aims to test the compound in diabetic retinopathy and Stargardt disease, a rare, genetically inherited form of macular degeneration.

A second drug that acts by a slightly different mechanism is being evaluated for macular degeneration by Sirion Therapeutics, a Florida-based pharmaceutical company. The compound is a synthetic vitamin A derivative that is thought to reduce toxin buildup by binding to one of the proteins involved in the reaction. According to preliminary results from tests of the drug in patients with late-stage dry macular degeneration, it can slow the scarring that is characteristic of the disease by 45 percent. However, scientists won’t know if the results are statistically significant until completion of the study next year. Because no treatments had been approved for dry AMD, in 2009, the U.S. Food and Drug Administration fast-tracked the drug, speeding the review process.

Radiation and Lucentis Combined to Treat Macular Degeneration

2010-05-27T09:55:00.000-07:00

by Randall V. Wong M.D

External beam radiation and Lucentis may be combined to treat wet macular degeneration. The results showed the treatment may be very safe and, when combined with anti-VEGF injections such as Lucentis, may decrease the need for frequently repeated injections.

Neovascularization, the growth of abnormal blood vessels, underneath the macular defines “wet macular degeneration.”
Radiation Kills Cells

Radiation treatments have been used in and around the eye to treat tumors. Radiation, in this case, halts the replication of cells. In the case of tumors, the lesions can no longer grow. So too, with neovascularization, new growth is inhibited. This is not the first study that has investigated the use of radiation for wet macular degeneration, but this is one of first trials combining external beam radiation with Lucentis.

Side Effects of Radiation to the Eye

Radiation can be toxic to the eye. It can cause cataracts, damage to the optic nerve and retina. It may also damage the lacrimal (produces tears to the eye) system and cause dry eye.

The investigators were able to dose and administer the radiation safely, seemingly able to avoid the usual complications of external beam radiation.
Treatment Required Fewer Injections of Lucentis

The gold standard for treating wet macular degeneration is now injections with either Lucentis or Avastin. The injections, however, need to be repeated as often as monthly. While highly successful, the need for repeated treatment requires a lot of trips to the office and can be expensive.

The study combined the use of the popular anti-VEGF agent, Lucentis (ranibizumab). The design of the trial required 2 initial injections during the first month of treatment.

52% of patients did not require additional injections for the 12 month study period (they only had 2!).

Also noteworthy, most patients stabilized and actually improved their vision.

What Does This Mean? This is not an approved treatment. It is in no way a true “study,” but this small trial still has some merits. It provides us with a small amount of evidence that alternative treatments using radiation may be useful.

First, recall that anti-VEGF injections, such as Lucentis or Avastin, now standard therapy for wet macular degeneration, were developed for chemotherapy against several types of cancers. The discovery that this improved patients with macular degeneration was coincidental.

For instance, patients receiving chemotherapy for colon cancer started noting improvement in their vision. Evidently, these patients had both cancer and wet macular degeneration.

External beam radiation has long been used for many types of cancer treatments.

In both cases, agents that halt rapidly dividing (i.e. growing) tissues should be effective in both the cancer treatment and the eye disease. The radiation stymies cell replication and the Lucentis (anti-VEGF) inhibits grow of new blood vessels. In the case of cancer, a tumor can not enlarge without blood supply.

So, it makes sense that this may work.

Lastly, this really underscores the need for treatments that do not need to be repeated so frequently, such is the case with Lucentis and Avastin. Right now, most doctors inject as frequently as every 4-6 weeks! Drug delivery systems designed to release drug over an extended period may aid this as well.

Macular Degeneration Wet Treatment

2010-01-22T20:56:00.000-08:00

The only way to treat the problem used to be by using a laser, though it has been shown to work only in about half the cases. Now there are chemical and laser-related options, too. Because blood vessel growth is associated with the presence of a ‘vascular endothelial growth factor,’ drugs that impair its function are expected to help. Another solution is to use modified RNA (ribonucleic acid) or sealing blood vessel leaks using lasers. Wet macular degeneration occurs to just 15 per cent of the people with age-related macular problems but are common in two-thirds of the people with a significant loss of vision. In 70 per cent of the cases, wet age-related macular degeneration weakens vision to 20/200 or worse within two years. Antioxidants (including vitamins A, C, and E, selenium, copper, lutein, and zeaxanthine) and zinc have been shown to help preserve vision. And it would help to make full use of vision from outside the central zone, that is, the peripheral vision, to maximum effect. Anti oxidants are known to protect by preventing free oxygen – which is found in high quantities in the blood vessel -rich eye.

For more information go to www.maculardegenerationassociation.org

How to Treat Macular Degeneration with Vitamins

2010-01-10T23:22:00.000-08:00

A popular treatment for Macular Degeneration is the use of vitamins, also known as Vitamin Therapy. Below are the popular vitamins that can be used to help treat Macular Degeneration. These vitamins can also be used to help prevent Macular Degeneration.

Step 1
Take a high potency Multivitamin. High potency Multivitamins provide the basic vitamins needed for eye health and can help to prevent future damage with Macular Degeneration.

Step 2
Take 45 mg of Zinc twice per day. Take each dosage along with 2 mg of Copper. Zinc is a necessary vitamin in proper vision and is also a strong antioxidant. Zinc has been proven to be effective in helping to patients with Macular Degeneration.

Step 3
Take 400 IU of a Vitamin E-Complex daily. Vitamin E-Complex works as an antioxidant and has been proven to help improve the vision in patients with Macular Degeneration that is age related. Always take your Vitamin E-Complex with a meal.

For more information go to WWW.MACULARDEGENERATIONASSOCIATION.ORG

Gene therapy to restore and improve vision

2010-01-04T09:34:00.000-08:00

Reduced vision, or even my blindness for an individual there are a number of reasons. The treatment is on what is the case depends, and the effectiveness of treatment. Conventional, non-invasive treatment has always wear glasses or contact lenses to correct vision problems. Developed over time, improving the eye-glass lenses and contacts that reduce glare, the wavelengths of the light side to improve depth perception, and to address many environmental problems.

More recently,There have been new developments in medical care for the blind have been. For example, Avastin, a drug that was originally intended, Colo-rectal cancer treatment has been found to improve vision in patients with macular degeneration, diabetic retinopathy and other retinal vascular disease in context. Non-steroidal anti-inflammatory drugs may reduce inflammation of the retina, and the formation of cysts. The new drugs have been developed to treat infections of cold cuts.

A majorChallenge has been on treatment options for genetic diseases and defects. These diseases result from the patient, and therefore limited treatment options. The future seems to be gene therapy. Recent clinical trials at the Scheie Eye Institute in Philadelphia made using gene therapy have dramatically improved sight-reading by the gesture declaration of letters on a table eye. These tests were sent to people who suffer from a congenital disease has been carriedLeber congenital amaurosis known. The study was later published in The New England Journal of Medicine. This implies a particular eye disease by a mutation in the gene RPE-65. This mutation prevents the gene is required for the production of a protein in the manufacture of the RPE. This protein is required for binding to the tissue of the retina and the light in sight.

The treatment included injection of normal RPE-65 gene directly into the retina. Two weeksthe contribution of all patients showed a better view. In addition, all participants were more sensitive to light. As a result the increase in visual acuity, there was a simultaneous decrease in abnormal eye movements, see further increases the ability of the eye.

While these studies have been performed on patients with a congenital disorder, there is no hope, other people with genetic diseases that help is on the move. With a little luck ', a disease of the retinathe past, because improving the methods of treatment.

For more information go to www.maculardegenerationassociation.org

What Is Goji Berries

2009-12-14T18:46:00.000-08:00

Long a staple of Asian and holistic medicine, the most renowned properties of the Goji Berries is its antioxidant properties and it provide several benefits including increased energy and heightened immune function.

The weight loss properties of this natural ingredient have recently seen the fruit becoming popular stateside as well, especially among celebrities in Hollywood with the Goji Berry being featured on many television programs and in magazines.

Goji Berry Active have improved the many benefits of the Goji Berry by adding other natural ingredients to the Goji Berry Active Supplement designed to provide many other health benefits and increase its weight loss capabilities as well.

A complete all-natural supplement is the result and it is designed in pill form that can be easily taken with no powders or cumbersome ingredients to mix or measure. Just take as directed to help with immune function, weight loss and increasing energy levels.

What are they?

Other Names: Lycium barbarum, wolfberry, gou qi zi, Fructus lycii

Goji berries grow on an evergreen shrub found in subtropical and temperate regions in the Himalayas in Tibet, China and Mongolia. They are in the nightshade (Solonaceae) family.

Usually Goji berries are placed out to be dried They are shriveled red berries that look like red raisins.

Gojo berries are used by people for what purpose?

For 6,000 years, herbalists in China, India and Tibet have been using Goji berries to:

• protect the liver

• help eyesight

• improve sexual function and fertility

• strengthen the legs

• boost immune function

• improve circulation

• promote longevity

Goji berries are rich in antioxidants, particularly carotenoids such as beta-carotene and zeaxanthin. One of the key roles of zeaxanthin is to protect the retina of the eye by absorbing blue light and acting as an antioxidant. In fact, increased intake of foods containing zeathanthin may decrease the risk of developing age-related macular degeneration (AMD). For people over the age of 65, AMD is the number 1 cause of blindness and vision loss.

Goji juice has become popular as a health drink in recent years. Companies marketing goji juice often mention the unsupported claim that a man named Li Qing Yuen lived to be 252 years old after drinking goji berries everyday . Marketers also list extensive health benefits of goji juice, even though there are few published clinical trials in humans.

What research are being done on goji berries?

Goji has only been tested on humans in two published studies. A Chinese study published in 1994 in the Chinese Journal of Oncology found that 79 people with cancer responded better to treatment when goji was added to their regimen.

There have been several clinical studies that show that goji berry contains antioxidants and that goji extracts may lower cholesterol levels, reduce blood glucose and prevent the growth of cancer cells. However, even when taken as a juice or tea, it doesn’t necessary mean that goji will have the same benefits.

Although like the ones used in traditional Chinese medicine, goji berries are rather cheap, goji juice is not cheap. Considering that be as high as 50 US dollars~for a price running as high as 50 US dollars for a 32-ounce bottle of goji juice (about an 18-day supply)}, the evidence isn’t compelling enough at this time to justify the cost of goji juice.

Also, we don’t know the regular consumption of goji will cause any side effects, or whether treatments or medications will be interfered with.

What do goji berries taste like?

A mild tangy taste that is slightly sweet and sour, that is how we describe the taste of goji berries. They have a similar chewy texture and shape as raisins.

Common forms

In traditional Chinese medicine, goji berries can be made into liquid extracts, brewed into a tea, added to Chinese soup or eaten raw

Goji juice is also available, usually in 32-ounce bottles.

Goji berries have appeared in snack foods in North America. For example, Trader Joe’s, the health food store sells a goji berry trail mix.

Possible drug interactions

Anticoagulant drugs (commonly called “blood-thinners”), such as warfarin (Coumadin®) may interact with goji berries. There was one case report published in the journal Annals of Pharmacotherapy of a 61-year old woman who had an increased risk of bleeding, indicated by an elevated international normalized ratio (INR). She had been consuming 3-4 cups daily of goji berry tea. Her blood work returned to normal after she stopped drinking the goji berry tea.

For more information go to www.maculardegenerationassociation.org

Can Heart Disease Treatments Combat Age-Related Macular Degeneration?

2009-12-03T20:52:00.001-08:00

Can treatments that reduce risks for cardiovascular disease (CVD) also help combat age-related macular degeneration (AMD), an eye disease that affects millions of Americans? CVD and AMD share some risk factors–such as smoking, high blood pressure, and inflammation–and a recent study found that people who have early-stage AMD are more likely to develop heart disease. This month's Ophthalmology
, the journal of the American Academy of Ophthalmology, reports on how two heart disease treatments, low-dose aspirin and statin medications, may impact AMD risk and disease progression.

Low-dose Aspirin May Offer Mild Protection from AMD

Records for 39,421women enrolled in the 10-year Women's Health Study (WHS) were used to evaluate the impact of low-dose aspirin on AMD risk. None of the women had AMD at the study outset; they were randomly assigned to take low-dose aspirin (100 mg on alternate days) or a placebo. It is known that low-dose aspirin substantially reduces the risk of serious blood vessel blockage, so researchers reasoned it might affect blood vessels that may play a role in AMD. Aspirin's anti-inflammatory and anti-oxidant effects were also considered potentially relevant. The research was supported by the National Eye Institute.

"Although our study found no large benefit from low-dose aspirin, the possible modest protective effect we did find warrants further study," said lead researcher William G. Christen, ScD, of Brigham and Women's Hospital, Boston, MA. "If future studies confirm our findings, it could be important to make the public aware of this benefit," he added.

The risk of developing vision-impacting AMD was reduced by18 percent in women who took low-dose aspirin. During the 10 year study, 245 AMD cases developed, 111 in the aspirin group and 134 in the placebo group. "Vision impact" was defined as a reduction in visual acuity to 20/30 or worse due to AMD. Though not statistically significant, the WHS risk reduction is similar to the result of the only other large randomized trial on this question: the Physicians' Health Study I, which followed 22,071 men who took low-dose aspirin or a placebo for five years.

The primary aim of the WHS was to learn whether Vitamin E and low-dose aspirin would help prevent heart disease and cancer. The AMD study also found that women who were not taking multivitamins appeared to benefit more from low-dose aspirin than vitamin users.

Statins Do Not Stop Advanced AMD

In the largest study of statin use by advanced AMD patients to date, researchers followed 744 patients enrolled in the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT) for five or six years. Statin drugs are primarily used to lower cholesterol in CVD patients, but they also affect mechanisms thought to impact AMD, including reduction of the inflammatory marker C-reactive protein. Earlier studies on statins' effects had been inconclusive. All patients from the CAPT cohort study were at risk for advanced AMD, but none had developed advanced "wet" or "dry" AMD at baseline. The study was supported by the National Eye Institute.

"The CAPT data did not support a large effect for statins in decreasing advanced AMD risk in patients who already had large drusen in both eyes," said lead researcher Maureen G. Maguire, PhD, Department of Ophthalmology, University of Pennsylvania. Drusen are whitish deposits, common in the eyes of people older than 60, which may signal AMD. Statin users were at slightly higher risk than non-users for developing advanced AMD, she said.

Dr. Maguire said several factors may be masking a protective effect for statins, the most important being that most patients who take statins for CVD are also at high risk for AMD. Only a randomized controlled trial could reveal statins' impact on AMD in the wider population, but since so many elderly people take statins it could be difficult to recruit a control group. It is also possible that statins may need to be taken for longer than the CAPT study's timeframe to show a protective effect, she added.

For more information go to www.maculardegenerationassociation.org

Avastin – Wet Macular Degeneration

2009-11-27T11:28:00.000-08:00

Learn more about ways to help stop your macular degeneration by clicking on this sentence.

Avastin is the brand name for Bevaciumab a monoclonal antibody or an antibody that is an identical clone of a single parent cell. It was approved in 2004 by the FDA for use in the treatment of some cancers and is used as a first or second line treatment for patients.

As the first clinically available angiogenesis inhibitor the United States it inhibits new cancer cells by blocking the growth of blood vessels in pre-existing tumors. A solid, non-liquid, tumor needs to grow additional blood vessels to be able to reach a certain size.

With an angiostatic agent such as Avastin the growth of new blood vessels is slowed stopping the cancer from growing indefinitely. It is usually given every 14 days intravenously in the arm and can be used with other drugs in combination and with intravenous 5-fluorouracil-based chemotherapy.

Developed by Genentech (NYSE: DNA), a leading biotechnology corporation, it is marketed in the United States under the Genentech name and outside the US under Roche.

When it was originally available in 2004 it was only FDA approved for the treatment of many forms of small cell lung cancer and metastatic colon cancer. A metastatic cancer, in this case colon cancer, is a cancer that spreads from one part or organ to another non-adjacent part or organ.

In 2008 the FDA opened up the doors and allowed for the treatment of breast cancer. There are also clinical trials under way to use Avastin for the treatment of non-metastatic colon cancer, metastatic renal cell carcinoma, metastatic breast cancer, metastatic glioblastoma multiform, metastatic hormone-refractory prostate cancer, metastatic or unresectable locally advanced pancreatic cancer, and metastatic ovarian cancer.

Avastin is also currently being used off-label, the practice of prescribing drugs for a purpose outside the scope of the drug’s approved label, for the treatment of wet macular degeneration by some retinal specialists.

Wet macular degeneration or AMD is a condition that causes loss of vision from the growth of abnormal blood vessel choriocapillaries, through Bruch’s membrane. This eventually leads to blood and protein leaking below the macula, an oval spot near the middle of the retina in the human eye. With AMD rapid, often irreversible vision loss can occur through the leaking, bleeding and scaring of the blood vessels if left untreated.

Dr. Philip J Rosenfeld, MD, PhD of the Bascom Palmer Eye Institute conducted a study that showed positive results for the treatment of AMD with Avastin. According to Dr. Rosenfeld’s study Avastin improved vision in as little as one week for patients treated for AMD.

For AMD treatment Avastin is used in very low amounts by retinal specialists. They usually have a pharmacists transfer the drug from the original vile to a pre-filled needles containing single doses. The specialists will then usually treat the patient in their own office.

As with any drug it is always best to talk to your doctor or pharmacist before starting any treatment.

For more information go to www.maculardegenerationassociation.org

New treatment proves that Macular Degeneration can be cured

2009-11-16T19:18:00.000-08:00

Micro Current Stimulation (MCS) which like acupuncture for the eyes. This procedure has proven results that will improved eye site from 20/100 to 20/60 and from 20/25 to 20/20. MD is the destruction of cells in the central part of the retina. A new revolutionary (MSC) treatment will reverse the disease. This treatment will re-generate the cells in the retina as it re-charges the cells and give them new life. This procedure increases the cells production of an energy chemical called ATP which creates new protein. Based on reports from patients this procedure has astonishing results.
For more information go to www.maculardegenerationassociation.org

Treatment for macular degeneration

2009-11-09T09:18:00.000-08:00

By Emily Singer
Molecular Sunglasses for Macular Degeneration
Dampening a light-sensing reaction in the eye might slow a common cause of blindness.

Molecules designed to slow the production of toxic byproducts in the eye by making it less sensitive to light are now being tested in patients with macular degeneration, the leading cause of blindness in people age 50 and older. If successful, the compounds would provide a much needed therapy for the disease, which affects more than 15 million people in the United States.
In macular degeneration, cells in the center of the eye, called the macula, deteriorate. A handful of new treatments for the more severe form of the disease, known as wet AMD, have been approved in recent years. But no treatments are yet available for the dry form, which accounts for about 90 percent of cases. Some dry cases ultimately progress to the wet form, which accounts for a large part of AMD-related blindness. “If you can treat dry AMD, you can kill two birds with one stone,” both reducing early symptoms and preventing progression to the wet form, says Paul Sieving, director of the National Eye Institute, in Bethesda, MD.
While scientists are still trying to understand the causes of AMD–age is the biggest risk factor, with genetics and lifestyle factors also playing a role–a growing pool of evidence suggests that the build up of specific compounds in the eye can hasten the cellular damage that underlies the disease. These compounds accumulate in the photoreceptors–cells in the retina that detect light–during normal eye function as the light-sensitive pigments in these cells change conformation in response to photons.
One form of the photopigment, a derivative of vitamin A, is highly reactive and leaks into nearby tissue called the retinal pigment epithelium. “Over time we think these compounds are a burden for the retinal pigment epithelium, which is essential for the healthy function of the photoreceptors,” says Janet Sparrow, director of the Retinal Cell Biology Laboratory at Columbia University, in New York. “In age-related macular degeneration, particularly the dry form, these cells die, and the photoreceptors follow.”
While this reaction is vital for sight, researchers believe that slowing the cycle in the subset of photoreceptors responsible for night vision, known as rods, could slow damage without having a large impact on daytime vision. (Preliminary results suggest it can affect dark-adaptation–when our eyes adjust to low-light conditions.) “During the daytime, the rods are spinning like crazy, wasting vitamin A for no good use,” says Ryo Kubota, an ophthalmologist and founder of Acucela, a Seattle-based startup that is developing treatments for macular degeneration. “It’s like a CCD camera pointed at the sun.”
One compound developed by Acucela that is in clinical trials inhibits the enzyme that converts the photopigment in photoreceptors from one form to another. This process happens only in the eye, allowing the drug to be administered systemically without affecting other tissue, says Kubota. The company has finished initial safety testing in humans and plans to begin a clinical trial assessing the compound’s effectiveness in patients with late-stage dry macular degeneration in a few weeks. Kubota also aims to test the compound in diabetic retinopathy and Stargardt disease, a rare, genetically inherited form of macular degeneration.
A second drug that acts by a slightly different mechanism is being evaluated for macular degeneration by Sirion Therapeutics, a Florida-based pharmaceutical company. The compound is a synthetic vitamin A derivative that is thought to reduce toxin buildup by binding to one of the proteins involved in the reaction. According to preliminary results from tests of the drug in patients with late-stage dry macular degeneration, it can slow the scarring that is characteristic of the disease by 45 percent. However, scientists won’t know if the results are statistically significant until completion of the study next year. Because no treatments have been approved for dry AMD, the U.S. Food and Drug Administration has fast-tracked the drug, speeding the review process.

For more information go to www.maculardegenerationassociation.org

AMD Drug And IOP; Getting Good Eyeglasses To Those In Need

2009-10-27T22:05:00.000-07:00

A first-time finding of intraocular pressure increases in patients with no personal or family history of glaucoma following anti-VEGF treatment for wet age-related macular degeneration (AMD), and a report on a simple, low-cost method that could revolutionize vision screening and treatment in developing countries, are highlights of today's Scientific Program of the 2009 Joint Meeting of the American Academy of Ophthalmology (AAO) and the Pan-American Association of Ophthalmology (PAAO).

The AAO-PAAO meeting is in session October 24 through 27 at the Moscone Center, San Francisco, CA. As the largest, most comprehensive ophthalmic education conference in the world, it offers United States and international Eye M.D.s more than 2,000 scientifically-based, peer-reviewed presentations including instruction courses, skills labs, "Breakfast with the Experts" roundtables and 900 research papers and posters.

Wet Macular Degeneration Treatment May Increase Intraocular Pressure

Some patients with age-related macular degeneration (AMD) develop elevated pressure within the eye (intraocular pressure, IOP) following treatment with anti-VEGF medications bevacizumab and/or ranibizumab, reports a Yale University School of Medicine study led by Ron A. Adelman, MD, MPH. Both of these anti-VEGFs control the abnormal growth of blood vessels in the eye's retina and are very effective against wet AMD, which can result in vision loss or blindness if untreated. But high IOP is a key factor in glaucoma, also a potentially blinding disease. Of 116 Yale study patients treated for wet AMD with either or both medications from 2006 to 2008, 3.45 percent (four patients) developed a significant and persistent rise in IOP.

"To our knowledge, ours is the first study to document persistent ocular hypertension (OHT) following intravitreal bevacizumab injections in patients with no personal or family history of glaucoma or ocular hypertension (OHT)," Dr. Adelman said. "We found that sustained, high IOP may occur after only one anti-VEGF injection, but more typically after multiple injections. Patients' OHT may continue over several AMD treatments and may require IOP-lowering therapy," he added.

The researchers also reviewed a report by S.F. Bakri and colleagues on persistent OHT after ranibizumab treatment. Of eight OHT patients total in the two studies, four had received a YAG posterior capsulotomy (a procedure related to cataract surgery) prior to wet AMD treatment, which might have predisposed them to OHT, Dr. Adelman said.

New Screening Method Could Mean Clear Vision for Millions

More than 150 million people globally–particularly in developing countries–struggle with poor vision because they cannot access appropriate eyeglasses. Earlier studies indicated that many could not meet the 20/60 vision driver's license standard, a level of impairment that makes daily tasks and economic success difficult. Seeking a low-cost solution, Thomas S. Shane, MD, Bascom Palmer Eye Institute, University of Miami, developed a method that uses a new electronic device called an auto-refractor, a vision chart, and pre-made eyeglasses.

Dr. Shane tested this method in high-poverty Mayan villages in southern Belize. Local health workers recruited people, and everyone over age 12 who came to the clinic within a five-day period was tested. In less than a minute per patient the auto-refractor assessed vision and reported the patient's lens prescription. Of 385 villagers screened 79 needed eyeglasses. Each person received new, pre-made eyeglasses with the appropriate lens strengths; then vision was tested again. On average, vision improved from 20/60 without glasses to 20/25 with glasses.

"This method requires minimal health care worker training and treatment time per patient," Dr. Shane said. "Costs are further minimized because eyeglasses with a range of lens prescriptions to treat the most common refractive errors could be produced and shipped in bulk. Compared to current practices in developing countries, our method may be much more effective, especially where the need is great but resources are limited."

For more information go to www.maculardegenerationassociation.org

Bionic Eye Opens New World Of Sight For The Blind

2009-10-22T20:50:00.000-07:00

Stem cells and electronics can help restore vision to people who’ve been blinded by retinal diseases, scientists reported in Chicago at Neuroscience 2009, the annual meeting of the Society for Neuroscience.

Diseases of the retina cause blindness by damaging the cells that line the back of the eye, where images of the world are normally transformed into nerve impulses that go to the brain.

“There’s very little therapeutic treatment out there tight now for people with diseased retinas,” says Brian Mech, a vice president of Second Sight Medical Products in Sylmar, Calif.

But Second Sight is hoping to change that. The company has developed an experimental bionic eye that has been tried in more than 30 patients with macular degeneration or retinitis pigmentosa.

Building An Artificial Retina

Each patient wears a pair of glasses that incorporates a video camera, Mech says. The video signal from the camera is sent to an implant on the eye itself, which in turns communicates with an array of electrodes attached to the patient’s retina.

And those electrodes do what the old retina can’t anymore: send electrical signals to the brain that allow sight.

Mech says it usually takes patients’ brains a little while to make sense of the new signals.

“They learn to use the device better over time,” he says. “Someone that has had the device for a year will do better than they did at three months.”

The artificial eye uses just 60 electrodes to replace millions of retinal cells. Mech says that means vision is rudimentary.

So people can find doors and follow lines on the floor. But most can’t read, and those who can only make out very large letters.

At the neuroscience meeting, Second Sight presented a study showing that patients could use the artificial eye to tell which direction an object was moving.

Despite the limitations of the artificial eye, Mech says patients who’ve gotten one tend to get emotional when they realize they can see even a little bit.

“There’s a lot of crying, a lot of smiling,” he says. “It’s a sensory input that they haven’t had in a very long time, and so they’re excited.”

Growing New Retina Cells

A team led by Robert Aramant of the University of California, Irvine, offered a different approach to restoring sight.

Since the 1980s, Aramant has been working to fix retinas damaged by diseases including macular degeneration and retinitis pigmentosa.

And for several years now, the team has been treating patients using fetal retinal cells. Their approach is to retrieve an intact sheet of fetal retinal cells and transplant the entire sheet into a damaged eye.

The transplanted cells then mature the same way they would in a developing fetus, creating all the layers of a normal retina, Aramant says.

The team has treated just 10 patients so far, because of funding constraints. But Aramant says seven of those patients got better, including one woman whose vision went from 20-800, which is severely impaired, to 20-200, which is good enough for many daily tasks.

After treatment, Aramant says, the woman was able to play computer games, write emails, and read a large-print version of Reader’s Digest.

Also at the meeting in Chicago, scientists presented studies showing ways to create new light-sensitive molecules in the eye, and to use stem cells to grow specific types of retinal cells.

For more information go to www.maculardegenerationassociation.org

MacuCLEAR And Mystic Successfully Complete Phase Ib Clinical Trial For Macular Degeneration

2009-10-13T14:38:00.000-07:00

MacuCLEAR, Inc. ("MacuCLEAR") and Mystic Pharmaceuticals, Inc., ("Mystic") announced preliminary successful results of a Phase Ib Clinical Trial for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). The preliminary results indicated that MacuCLEAR's MC-1101 drug is safe and well tolerated by study participants, and has a biological effect on blood flow in the back of the retina. Mystic's VersiDoser™ ophthalmic delivery system was used by trial participants to self-administer MC-1101 to the front of the eye during the trial. The study included Proof Of Concept ("POC") indicators. A key finding of the study was the successful migration of the drug to the back of the eye.

"We are very pleased with the groundbreaking results of this study," said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. "We have confirmed the safety of MC-1101 in humans, a primary endpoint for the study." Ralston added, "We are excited about the implications of the proof of concept part of this study. Using special laser Doppler flow instrumentation, we showed MC-1101 gets to the back of the eye and significantly modulates the blood flow in the choroid, the tiny blood vessels in the back of the macula portion of the retina. This study provides additional scientific evidence supporting our theory that restoring blood flow in the choroid will have a positive affect on preventing the progression of this terrible disease that is the leading cause of blindness for people over the age of 50 in the world." MacuCLEAR will publish the full results of study later this year.

Mystic Pharmaceuticals' President and CEO, Timothy Sullivan, stated, "We are pleased to have partnered with MacuCLEAR to develop a drug/delivery system combination that has the potential to provide a simpler, safer and ultimately cost effective solution to the millions of people suffering from this disease." Ralston added that, "Mystic's delivery system provided key benefits for both MacuCLEAR and the trial participants. Mystic's novel unit dose approach to packaging each eyedrop individually enabled us to use a preservative free formulation and the control Mystic's technology provides for calibrated precision dose delivery and spray plume definitely enhanced absorption of the drug to the back of the eye." Patients were able to safely and effectively self-administer MC-1101 throughout the trial using the VersiDoser system. "An overwhelming majority of the trial participants expressed a strong positive preference for using the VersiDoser Delivery System over traditional eye drop delivery," Sullivan concluded. Mystic will publish study results of trial participant preferences for its VersiDoser Delivery System later this year.

Ralston and Sullivan presented a summary of the trial results at the Texas Emerging Technology Fund Investment Symposium on October 8, 2009 at the Renaissance Hotel in Richardson, Texas. MacuCLEAR and Mystic presented the status of the progress of their companies at this symposium featuring companies that have received investments from the State of Texas Emerging Technology Fund.

For more information go to www.maculardegenerationassociation.org

NeoVista Presents 24-month Visual Acuity Data Outcomes of Novel Therapy for the Treatment of Neovascular Age-Related Macular Degeneration

2009-10-05T21:38:00.000-07:00

NeoVista, Inc. made public today at the Combined Retina Meeting, 24-month data from the company's Phase II study (NVI-111). The study was designed to examine the company's novel epimacular brachytherapy procedure when used in conjunction with Bevacizumab anti-VEGF therapy for the treatment of neovascular age-related macular degeneration (AMD). The long-term data from the study showed that a majority of patients maintained their visual acuity and at least 20% also experienced a marked improvement in vision at month 24. The data also showed that 76 percent of the patients only needed 2 protocol required injections of Avastin® throughout the 24-month period.

"We're excited with the latest data from this Phase II study, said John N. Hendrick, President and CEO of NeoVista. "Safety remains the primary purpose of this study and to date there is no evidence of long-term radiation toxicity at 2 years follow-up, with many patients being followed for as long as 3 years. A large majority of patients in the study maintained their visual acuity over the course of follow-up, while some patients in the trial experienced significant vision gain. We are encouraged by the reduction in the number of injections delivered to patients in this study (mean of 2.4 injections over the 24 month period). This therapy has the potential to decrease treatment burden both for patients and physicians, not to mention the overall financial burden for healthcare systems around the world."

In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers a focused dose of energy directly to the choroidal neovascular lesion without damaging the adjacent healthy retinal vasculature. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epimacular device is less than that from a typical chest x-ray.

The ongoing multicenter feasibility study enrolled 34 trial participants (with a mean age of 72 years) from June 2006 to April 2007 at two centers in Brazil and one in Mexico. These patients, with predominantly classic, minimally classic, or occult (with no classic) choroidal neovascularization (CNV), received a single exposure of epimacular brachytherapy in combination with two intravitreal injections of Avastin, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in. Additional therapy was delivered based upon the investigator's evaluation of disease activity.

There was an expected increase in the incidence (50%) of cataract formation related to the vitrectomy, the surgical procedure performed when administering epimacular brachytherapy. Comparative data was examined to look at outcomes of patients who entered the study with their natural lens versus those who had already undergone cataract surgery. This analysis showed that 80% of patients who had cataract surgery prior to study entry maintained their visual acuity and 30% gained significant vision at 24 months. When comparing to the cohort of patients that entered the study with their natural lens, 65% percent of patients maintained their visual acuity and 20% percent had significant vision gain, highlighting the fact that cataract formation played a role in long term visual acuity data..

There were a limited number of adverse events in the trial which were related to the vitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage), rather than the epimacular brachytherapy. To date, no instances of radiation toxicity have been reported with many patients followed for as long as 3 years.

The data were presented by Pravin U. Dugel, MD, managing partner, Retina Consultants of Arizona, Phoenix, AZ. "The potential of this treatment is enormous", said Dr. Dugel. "I believe that epimacular brachytherapy will be used in combination with the current standard of care to make this treatment more effective by offering a broad spectrum of action. In addition, epimacular brachytherapy may also improve the quality of life for our patients by relieving them from having to receive monthly intraocular injections. The potential impact of epimacular brachytherapy for patients, physicians and the entire healthcare system is prodigious".

NeoVista has recently completed enrollment in the company's first pivotal trial, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that has enrolled 450 subjects at 45 sites worldwide, and is evaluating the safety and efficacy of NeoVista's therapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis® (ranibizumab) versus Lucentis alone.

For more information go to www.maculardegenerationassociation.org

ThromboGenics Completes Patient Enrolment in US Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease

2009-09-25T17:24:00.000-07:00

LEUVEN, Belgium, September 24 /PRNewswire-FirstCall/ --

- Enrolment of 326 Patients Completed Ahead of Schedule

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-006 has completed enrolment with a total of 326 patients several months ahead of schedule. The second Phase III study with microplasmin, TG-MV-007, which is recruiting patients in the US and Europe is due to complete enrolment in the first half of 2010 as planned. Enrolment completion in this study means that ThromboGenics is a step closer to becoming a profitable, integrated Company focused on cutting edge ophthalmic medicines.

Microplasmin's Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. This program involves two clinical trials, which are taking place in the United States (TG-MV-006 trial) and Europe and the United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125microg of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.

The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye. Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions such as macular hole formation, and some forms of macular edema. Vitreomacular adhesion is also associated with a much poorer prognosis in certain major eye conditions, including diabetic retinopathy and Age-related Macular Degeneration (AMD).

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using optical coherence tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. ThromboGenics has used both OCT and ultrasound technology in previous studies evaluating microplasmin in eye disease. Based on this experience and discussions with the FDA, OCT was selected as the main assessment technique for the Phase III program as it provides results which have greater clinical relevance. In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period.

It is expected that the results from the TG-MV-006 study will be presented by mid 2010.

Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleased to announce that we have completed enrolment of the US pivotal Phase III trial for microplasmin months ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is very encouraging. Today's announcement brings us a step closer to potentially changing the way a number of important eye conditions are treated, as well as bringing us closer to our key aim of becoming a profitable, integrated business focused on cutting edge ophthalmic medicines. We very much look forward to announcing the results of this trial by the middle of next year and I am confident that ThromboGenics will continue to deliver on the milestones needed to build a strong, successful and profitable Company."

For more information go to www.maculardegenerationassociation.org

Zeaxanthin Supplements Help Prevent Age-Related Macular Degeneration

2009-09-18T09:43:00.000-07:00

Author: Lisa Murray

Living longer is what people do now. The number of people suffering from age related disease is on the increase. One of the things people value the most is their sight so what can we do to protect our vision, we can add a supplement called zeaxanthin to our daily diet. Zeaxanthin is a carotenoid found in the central macula of the eye and it helps us to see things straight in front of us such as signs and faces.

A lot of optometrists and ophthalmologists are recommending zeaxanthin supplements for their older patients that are at high risk for age-related macular degeneration. Age-related macular degeneration or AMD is the major cause of blindness in the elderly and simply taking a daily dose of zeaxanthin can help prevent AMD from occurring.

AMD affects 10% of people aged 66-74 years and 30% aged 75-85 years of age. If you have a relative with AMD your chances of developing this disease increase to 50%. Taking a zeaxanthin supplement can change these odds.

Some doctors are recommending zeaxanthin supplements for younger patients as a preventative measure and if doctors are recommending it as a supplement then that lets you see just how important zeaxanthin is to your eyes, your sight and your way of life.

How would it be that, for the sake of one supplement containing 10mg of zeaxanthin you lost your independence, you could no longer see the faces of your family or your favourite books became unreadable. This supplement is more important than ever as we as a society age and demand that we retain our health and our senses while we do so.

Imagine looking at a photograph of a loved one and not being able to see their face. Think about how it would feel to pick up a book or magazine and not be able to read the words right in front of you. Zeaxanthin can help prevent this from happening to you. Imagine your favourite sport, chat show, drama, film or soap opera on the television and not being able to see what was going on in the middle of the screen. Now imagine that you chose a zeaxanthin supplement that suited your needs, took it regularly and made it a part of your health maintenance routine and you won’t have to imagine the loss of your central vision.

Of course zeaxanthin occurs naturally in our eyes and therefore can be found in other places in nature such as fruit and vegetables. Although many of us have improved our diet and take to heart the advice of five portions of fruit and veg each day, this is such an important health issue that it makes sense to ensure that we get enough zeaxanthin into our diet by taking it in supplement form to compliment our healthy eating plans.

As part of what we do we have scoured the supplement market place and found what we believe to be one of the best zeaxanthin supplements currently available. After thoroughly investigating this topic three of our researchers have started taking a zeaxanthin supplement and they are in their thirties. Your sight is something that can be protected from AMD whatever your age, why not start today.

Lisa Murray is an editor of http://www.supersupplementguide.com and is a keen advocate of ensuring your body is properly fueled with the right nutrients in order to give you the healthiest life possible. She does this by taking a carefully balanced multi-vitamin daily. Why not join her today and live life to the fullest for longer.

For more information go to www.maculardegenerationassociation.org

New techniques slow progress of age-related vision loss

2009-09-09T10:28:00.000-07:00

(CNN) -- When Albert Budacz was young, he prided himself on having good eyesight; he never wore glasses. But as he eased into his late 40s, he couldn't see as well. "I noticed a change in my vision," he explained. "Primarily in church when I would open a Bible, or something like that, I had to position myself under a light to see it."

Concerned that he was beginning to lose his sight, Budacz went to his ophthalmologist, Dr. Sharon Solomon with the Wilmer Eye Institute at Johns Hopkins. He was found to have the beginnings macular degeneration, an eye condition that occurs when the central portion of the retina -- called the macula -- begins to deteriorate.

Until recently, people with age-related macular degeneration, the leading cause of severe vision loss in Americans older than 60, had few treatment options. But now, thanks to new research and advancing technology, there are more vision-saving choices.

Early signs of macular degeneration-related vision loss include shadowy areas or fuzzy distortion in a person's central vision.

"A patient told me recently that he noticed when he was driving that the streetlights were slanted; the poles themselves were slanted," Solomon said. "That's a classic sign of the beginning of this disease."

Although obesity, smoking, high blood pressure and certain drugs can cause it, age is the primary risk factor.

"As people approach their 50s and later, they may have little yellow deposits that develop underneath the retina, and that's called drusen," Solomon explained. "Those deposits are the hallmark of what we call early age-related macular degeneration."

There are two forms of age-related macular degeneration, or AMD: the dry form, known as non-neovascular, and the wet form, called neovascular.

The dry form, which Budacz has, is more common. According to the National Eye Institute, about 85 to 90 percent of patients with advanced macular degeneration have the dry form.

Dry macular degeneration is caused when drusen begin to accumulate in and around the macula. Drusen, those yellowish deposits, are debris from deteriorating tissue.

With dry AMD, there is usually a gradual loss of central vision. Over a period of years, dry AMD can progress to a gradual deterioration of retinal cells, which can result in severe vision loss or lead to the wet version of AMD.

As of now, there is no FDA-approved treatment for dry macular degeneration, although a few drugs and devices are in clinical trials.

However, studies have shown that supplements and a healthy diet can slow the progression of dry macular degeneration. A recent National Eye Institute study found that certain nutrients such as beta carotene (vitamin A) and vitamins C and E may reduce the risk of progression of early-stage AMD by 25 percent.

Solomon says these antioxidants have a positive effect. "They're known as 'preservision,' " she said, noting that they are commonly given to certain patient groups to slow their progression to advanced macular degeneration.

Other research has shown that B6, B12 and folic acid may help prevent age-related macular degeneration. In a study of more than 5,000 women, researchers noted those who took a combination of B6 and B12 vitamins along with a folic acid supplement had a 34 percent lower risk of developing AMD then those taking a placebo.

Although the studies showed strong results, the American Academy of Ophthalmology cautions patients to talk to their eye doctors about which supplements are best for their condition before they start popping vitamins.

In the wet version of macular degeneration, abnormal blood vessels grow beneath the retina and leak blood and fluid. This leakage causes permanent damage to light-sensitive retinal cells, which die off and create blind spots in central vision.

Doctors say it's the body's misguided way of attempting to supply the retina with more nutrients and oxygen. Instead, the attempt creates scarring, leading to severe central vision loss.

Up until recently, there's been very little doctors could do for the wet form of macular degeneration. But over the past decade, there have been a few treatments developed to slow its progression. Cold lasers are now used to freeze the abnormal blood vessels responsible for destroying the macula; they have a 60 percent success rate.

And within the past three years, researchers pinpointed a protein in the eye, called vascular endothelial growth factor, that stimulates the development of blood vessels.

Injectable drugs that inhibit VEGF are now FDA-approved and available; without VEGF, there is little to encourage the growth of blood vessels in the retina.

"They actually have a 90 percent chance of stabilizing vision and a 30 to 40 percent chance of improving vision," Solomon said. "This is the first therapy that we've had that can actually [reverse] vision loss."

Most ophthalmologists prefer an ounce of prevention to a pound of cure. They promote yearly eye exams as the easiest way to keep macular degeneration in check -- and warn against waiting for a crisis to schedule a checkup.

"We typically pick up a patient when, all of a sudden, they've had an acute, abrupt loss of vision or change in the quality of their vision," Solomon said. "And sometimes it's too late."

Albert Budacz was lucky. He caught his macular degeneration in time. He's stopped smoking and takes antioxidants to slow the progression of the disease. And although he may not have the eyesight he had as a young man, he can still see pretty well with or without glasses. And to him, that's all that matters.

For more information go to: www.maculardegenerationassociation.org

See Clearly With Nutrients

2009-09-02T18:35:00.000-07:00

Vision problems plague many people as they get older, and whether it's an inability to read fine print, dry eyes, floaters, or macular degeneration, these impairments interfere significantly with quality of life. That's why for more than a decade I've recommended lutein, zeaxanthin, zinc, bilberry, and other nutrients that target eye health.

These nutrients consistently provide good results-in fact, in just the past month I've heard from three subscribers who began using them. One woman reported that her macular degeneration, a progressive condition that is the leading cause of blindness in older people, is now under control and holding steady. Another says they help with her vision and dry eyes. And a 93-year-old man told me that now his 40-year-old relatives depend on him to read fine print! Look for vision products that contain 15 mg of lutein, 600 mcg zeaxanthin, 50 mg zinc, and 320 mg bilberry, among other nutrients.

Scientists Morph Human Skin Cells Into Retinal Cells

2009-08-28T12:21:00.000-07:00

By Molika Ashford

In a stem-cell breakthrough, scientists have illuminated a new way forward in treating diseases of the eye: turning skin cells into eye cells.
The retina is a lush layered field of tissue lining the back of the eye, a complex mix of specialized cells that serve as a transfer station where light signals are absorbed and sent to the brain to be translated into sight.

Researchers from University of Wisconsin, Madison have now created these unique retina cells from lowly skin cells -- opening the possibility that patients with damaged or diseased retinas might some day be able to grow themselves a cure from their own skin.

First, scientists turned the skin cells into IPS cells (induced pluripotent stem cells), the skin-derived stem cells that have emerged as an alternative to embryonic stem cells. Bathed with a cocktail of chemicals, the IPS cells were then morphed into a variety of retinal cells, including the all-important photoreceptors that translate light signals into electrical signals for our brains to parse as vision.

The scientists report that it is exciting not only to be able to create multiple types of retinal cells, but also that the process appears quite similar to normal retinal development (except in a plastic dish). The group also created retinal cells with embryonic stem cells, but the skin cell method offers an advantage -- patients with genetic diseases of the retina could use their skin to grow a crop of diseased retina cells, which could then be subjected to a variety of test treatments in the lab, hopefully hitting on something that works someday.

The cells might also serve as a treatment themselves, whether grown from IPS cells or embryonic stem cells. Previous studies have improved vision in mice by treating their retinas with stem cells, and this development might help extend that research to humans.

Though in a very early stage, the project is a strong step toward new treatments for an array of debilitating vision disorders.

UF reports possible breakthrough on treating macular degeneration

2009-08-04T12:57:00.000-07:00

By Diane Chun
Staff writer

Published: Saturday, August 1, 2009 at 5:30 p.m.
Last Modified: Saturday, August 1, 2009 at 5:30 p.m.

A new approach to repairing damaged retinas in mice offers a ray of hope for some two million Americans with an age-related eye condition called macular degeneration.

University of Florida researchers report that they were able to program adult stem cells from mice to transform themselves into vision cells, suggesting a potential treatment for one of the most common causes of vision loss in older people.

In a paper to be published in September's Molecular Therapy, scientists describe how they used a virus carrying a gene that gently pushed cultured adult stem cells toward a fate as retinal cells. When the cultured cells were reintroduced into the mice, they were completely transformed into the desired type of vision cells.

"To our knowledge, this is the first reported use of targeted gene manipulation to specifically program an adult stem cell to become a new cell type," said Dr. Maria Grant, professor of pharmacology and therapeutics in the UF College of Medicine.

Ultimately, Grant said, the findings suggest that the same thing could be done with drugs.

"You would not give the drugs to the patient," she explained, "you would give the drugs to their cells. Take the cells out, activate certain chemical pathways, then put the cells back into the patient."

The researchers were able to use chemical compounds that mirrored environmental conditions in the body to point the stem cells toward their ultimate identities as vision cells.

In essence, they were successful in tricking the stem cell into thinking it is a retinal cell and behaving accordingly.

"This implies a whole new field of stem cell research that uses drug manipulation rather than genetic manipulation to send these immature cells along a new pathway," said Grant.

She collaborated in the work with Edward Scott, director of the program in stem cell biology and regenerative medicine at UF's McKnight Brain Institute.

"This work applies to 85 percent of patients who have age-related macular degeneration," Grant said. "There are no therapies for this devastating disease."

for more information contact www.maculardegenerationassociation.org

Study Published In PNAS Reveals Side Effects Of Experimental "Gene-Silencing" Treatment

2009-07-12T19:16:00.001-07:00

The side effects of an experimental "gene-silencing" treatment that is currently being investigated for a variety of diseases are even more wide-ranging than previously discovered, according to a study by a University of Kentucky researcher.

Following up on groundbreaking research published last year in the journal Nature, Dr. Jayakrishna Ambati, a UK ophthalmologist , and his colleagues found that the new drug modality, siRNA (21-nucleotide small-interfering RNA), is toxic not only to blood endothelial cells, which line blood vessels, but also to the cells lining the lymphatic channels.

These findings reinforce the note of caution sounded by Ambati's previous Nature study, which has been cited nearly 50 times and highlighted in special reviews in premier journals such as Cell and in Nature, which termed it "stunning." But these side effects could themselves find useful application, for example, in cornea transplantation, where growth of new blood and lymph vessels is believed to be a major cause of graft failure.

The new findings are published in this week's online issue of Proceedings of the National Academy of Sciences, the official journal of the U.S. National Academy of Sciences.

In the earlier study, the Ambati laboratory discovered previously unrecognized immune side effects of siRNA, which is currently in FDA trials for numerous diseases including age-related macular degeneration and life-threatening viral infections.

Specifically, they showed that in two different established animal models of new blood vessel growth, siRNA killed these cells by activating an immune receptor called toll-like receptor 3 (TLR3). This was a critical finding, as immune and blood vessel toxicities were not believed to occur with this pharmacologic technique. As a result, siRNA is now recognized as a new class of anti-vascular drugs that could potentially be used to treat some of the 10 percent of the world's population suffering from neovascular diseases. However, this first study did not address other forms of specialized endothelial cells that exist in the human body, including those that line the lymphatic system, a critical component of immune responses. The new study found that siRNAs block not only blood vessels but also lymphatic vessels. In the cornea, the clear part of the eye, injury often leads to the formation of both blood and lymphatic vessels. In fact, the formation of lymphatic vessels after corneal transplantation is purported to be a major mechanism through which transplant rejection occurs. Ambati's lab found that corneal injections of siRNA suppressed both blood and lymphatic vessel growth via endothelial cell toxicity.

Won Gil Cho, post-doctoral fellow, Dr. Romulo Albuquerque, and Dr. Mark Kleinman, researchers in the Ambati laboratory, also showed that siRNA directly activates TLR3, the first time this has been demonstrated in the literature. Addditionally, they showed, using time-lapse studies, that siRNA does not enter cells without a cell-permeating moiety such as cholesterol. This is important, because siRNA must enter cells in order to function as intended by specifically degrading intracellular messenger RNA bound for protein-forming machinery. Furthermore, this finding strengthens their finding that TLR3 positioned on the cell surface is responsible for mediating the toxic side-effects of siRNA. In concert with Sandro De Falco and Arturo Brunetti, researchers in Naples, Italy, they also found that siRNAs generically block blood and lymphatic vessel growth in muscle tissue as well. These findings illustrate this side effect of siRNA can occur in many parts of the body.

Ambati's lab also reported last year in the New England Journal of Medicine that siRNA is deleterious to other cell types, such as the retinal pigmented epithelium, which is involved in age-related macular degeneration.

"This may be a broadly imprinted response in the mammalian immune system that is activated by siRNA," Ambati said. "In terms of benefit, siRNA may be utilized in the treatment of diseases of the lymphatic system, including lymphangiomas for which there is currently no effective targeted pharmacologic intervention."

Ambati is a Doris Duke Charitable Foundation Distinguished Clinical Scientist and a Burroughs Wellcome Fund Clinical Scientist in Translational Research. His laboratory is also supported by the National Eye Institute of the NIH, Research to Prevent Blindness, and American Health Assistance Foundation.

Exploiting Cortistatins' Essence

2009-06-06T15:19:00.000-07:00

Simple analogs of a complex natural product may protect against loss of vision
Carmen Drahl

By making simplified versions of cortistatins, marine natural products that halt new blood vessel growth, researchers can treat excessive vessel growth in mice with macular degeneration. The analogs may inspire a new class of medications for the disease, which is a leading cause of vision loss.

Cortistatins A and J are potent blockers of angiogenesis, or new blood vessel growth, but the natural supply is scarce and chemical syntheses of the cortistatins haven't produced enough material for animal testing. Chemists Barbara Czakó, László Kürti, and E. J. Corey at Harvard University decided to study analogs instead.

"What distinguishes cortistatins are two basic groups at opposite ends of a steroidlike scaffold that are important for bioactivity," Corey says. His team incorporated those essential groups, a dimethylamino and an isoquinoline group, on opposite ends of an easy-to-build steroid and made refinements to optimize anti-angiogenic activity in cells. In collaboration with vascular biologists Akiko Mammoto and Donald E. Ingber of Harvard Medical School, they found that some of their compounds blocked angiogenesis in a mouse model of macular degeneration but did not show signs of toxicity in cellular assays (J. Am. Chem. Soc., DOI: 10.1021/ja902601e).

The most effective pharmaceutical treatment for macular degeneration is administered by injection into the eye, Corey notes. All of his team’s most potent analogs are water soluble and could lead to an eye-drop-based treatment, he says.

Chemist Samuel J. Danishefsky of Memorial Sloan-Kettering Cancer Center and Columbia University praised the work, saying that Corey's team “has increased the scope of the cortistatins by weaving them into a steroid setting which provided a doable terrain for chemical synthesis.”

"In terms of an exercise in blending intuition and rational discovery, this paper could emerge as a classic," Danishefsky adds.

Studies from other groups suggest that inhibitors of the particular angiogenesis pathway that the cortistatin analogs target may lead to side effects, cautions David A. Cheresh, who studies tumor angiogenesis at the University of California, San Diego. Nonetheless, the analogs "represent exciting new leads in the search for the next class of anti-angiogenic agents" and should be studied further, he adds.

Corey tells C&EN that the cortistatin analogs are effective in mice at very low doses of less than 1 mg and would also be locally administered. Therefore, the amount of drug that the rest of the body would see is likely to be essentially zero, vastly reducing the potential for side effects, he says.

In related work, independent teams led by Hiromasa Kiyota at Tohoku University in Japan and Phil S. Baran at Scripps Research Institute have tested simplified cortistatins in cells, but neither team has reported animal studies (Biosci. Biotechnol. Biochem. 2008, 72, 2992; Angew. Chem. Int. Ed., DOI: 10.1002/anie.200901116).

First Bionic Eye to Undergo Clinical Tests by 2011

2009-05-30T20:52:00.001-07:00

The first clinical tests of a bionic eye are likely within two years and commercialization within five, according to researchers.

A bionic eye is a form of neural prosthesis intended to partially restore lost vision or amplify existing vision.

There is a lot of promising research being done right now. We are living in a very exciting time.

However, we can't put our plans and dreams on hold until this research delivers a cure.

I will never forget the day that I discovered a Telesensory video magnifier in a university library. It was 1977. I was just about to drop out of college before I made this discovery.

That video magnifier made it possible for me to complete college and live my dream as a public school teacher for 21 years!

Today I am very proud to own Amazing Video Magnifiers where I distribute only Telesensory video magnifiers.

They are, in my opinion, the most reliable and cost efficient.

I encourage you to visit the site and read about the various outstanding units.

New Medical Study Establishes First-Ever Long-Term Benefits for Macular Degeneration Sufferers Using Macular Health Vitamin Supplement

2009-05-10T09:59:00.000-07:00

New Medical Study Establishes First-Ever Long-Term Benefits for Macular Degeneration Sufferers Using Macular Health Vitamin Supplement

Eye disease product has the potential to preserve vision for millions

BIRMINGHAM, Ala., April 28 /PRNewswire/ -- As many as 17.8 million people will suffer from age-related macular degeneration (AMD) by 2050 and 1.57 million will be blind from the disease, according to the U.S. Centers for Disease Control and Prevention. However, a new medical study by a group of retina specialists at the Callahan Eye Foundation Hospital at the University of Alabama Birmingham (UAB) indicates that with the use of the Macular Health vitamin supplement there is a way to reduce these numbers and potentially preserve the vision of millions.

The second phase of the Multifocal Electroretinogram (MERG) study recently revealed that patients suffering from AMD experienced long-term benefits from taking Macular Health, a special combination of supplemental vitamins, minerals and carotenoids. Phase I of the MERG study, completed in 2005, confirmed an average of 16 percent improvement in vision after taking Macular Health for only 12 weeks. Phase II measured the vision function of the same patients two years later and found an average improvement in vision of 17 percent.

"The outcome of this study is extremely encouraging for sufferers of age-related macular degeneration," says John O. Mason, III, MD, researcher and retinal specialist at the Callahan Eye Foundation Hospital. "These new findings prove that Macular Health can slow vision loss and actually improve vision function over time."

MERG testing was used to gauge the vision of AMD patients before and after using the Macular Health supplement. The test results of patients taking Macular Health were compared to results of a control group that did not take the supplement. Phase II of the study was accepted by the Association for Research and Vision in Ophthalmology (ARVO) for poster presentation. Mason and a team of retina specialists will continue to monitor study participants to evaluate improvement in eye health and vision with the use of Macular Health.

Jeffery McAnnally, President of Macular Health, LLC, says, "On behalf of the Macular Health Company, I am pleased to share this additional proof of Macular Health's effectiveness. Not only is Macular Health the most affordable product of its kind on the market today, it is the easiest to take."

An estimated 9 million people currently suffer from AMD, and one-third of adults over 70 are afflicted with this incurable disease. AMD is the leading cause of blindness in Americans 50 years of age and older. AMD is a breakdown of the macula of the eye that typically occurs during the aging process. Damage of the macula increases the difficulty of seeing fine details and even faces clearly.

To learn more about age-related macular degeneration or the Macular Health vitamin supplement, visit www.macularhealth.com. To speak with John O. Mason, III, MD, please contact Julie Ward at 205.503.5955 or julie@styleadvertising.com.
Website: http://www.macularhealth.com/

Possible Cure on Horizon

2009-05-03T02:04:00.000-07:00

It's a sight for sore eyes.

Stem cell therapy to cure blindness is being developed by British scientists, and surgeons believe it could become a simple procedure that will be available in six or seven years' time, the London Times reported.

The process involves replacing a layer of dying cells with fresh ones created from embryonic stem cells.

It targets age-related macular degeneration (AMD), one of the most common causes of blindness, which involves the loss of eye cells.

"This is a huge step forward for patients," Tom Bremridge, chief executive of the Macular Disease Society, told the Times. "We are extremely pleased that the big guns have become involved, because, once this treatment is validated, it will be made available to a huge volume of patients."

Embryonic stem cells have the ability to develop into all types of body tissue.

Their use is controversial, however, because it involves the destruction of human embryos.

Lab tests done by the British team have shown that stem cells can prevent blindness in rats, and similar elements work on pigs.

A clinical trial is expected within two years.

It will most likely be the second in the world to use embryonic stem cells on humans. The first, spinal cord injury sufferers, will start later this year in the United States.

Sirion gets FDA Fast Track designation for sight-preserving drug

2009-04-26T03:49:00.000-07:00

Sirion gets FDA Fast Track designation for sight-preserving drug
Tampa Bay Business Journal

Sirion Therapeutics Inc. announced positive results from a clinical trial evaluating a treatment for certain persons with macular degeneration.

The Phase II trial evaluated fenretinide as a treatment for geographic atrophy associated with age-related macular degeneration.

Sirion describes fenretinide as an oral vitamin A binding protein antagonist. Geographic atrophy is the most advanced form of dry age-related macular degeneration.

An analysis of the Phase II data showed slower growth of lesions in patients treated with oral fenretinide than in patients who received a placebo, a release from Sirion said.

Sirion will continue the Phase II study and will meet with scientific advisers and the Food and Drug Administration to design a Phase III study, the release said.

The effort by Sirion to develop fenretinide as a treatment got an additional boost when the FDA granted it Fast Track designation, the release said. Fast Track programs of the FDA are designated to facilitate the development of drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition.

Sirion is a privately held biopharmaceutical company based in Tampa focused on discovery, development and commercialization of products to protect and preserve eyesight.

2009-04-19T05:00:00.000-07:00

New Drug May Help Treat, Reverse Advanced Macular Degeneration
Apr 13, 2009
Reporter: CBS News
Email Address: news@kbtx.com

As the baby boomers age and live longer, a severe sight problem called Macular Degeneration is becoming more common.
But, there are new treatments to help the condition that can lead to blindness.
Sylvia Moore was diagnosed with macular degeneration three years ago.
"If I look straight ahead at somebody's face, I don't see them at all, you'd see a blank spot, a black spot," says Moore of the disease.
Macular Degeneration is most common in seniors.
It happens when blood vessels in the back of the eye start leaking and is the leading cause of blindness in people over 65.
The good news is doctors now have more weapons than ever to fight the condition, and in some cases even reverse it.
When it's caught early, vitamin therapy can slow down the progression of macular degeneration, and in some cases laser surgery can halt vision loss.
But the latest treatment is a drug that's injected directly into the eye.
The medication targets the abnormal blood vessels leading to its shutdown and hopefully to the improvement in vision.
Moore has been getting the injections for three months and is already seeing a difference.
"Its scary when you see a needle coming at you but it doesn't hurt.... I'd rather have that than blindness," Moore says.
A new study predicts some 9 million americans will be diagnosed with macular degeneration next year.
That number is expected to double in the next 40 years.

Eye 'compensates for blind spot'

2009-04-11T03:37:00.000-07:00

Eye 'compensates for blind spot'
Eye Peripheral vision is retained

Partially sighted and registered blind people can be taught to read and see faces again using the undamaged parts of their eyes, say experts.

When only the central vision is lost, as with the leading cause of blindness, age-related macular degeneration, peripheral vision remains intact.

And patients can be taught to exploit this, the Macular Disease Society says.

It has developed a training scheme and is calling for professionals to adopt the system across the UK.

The macula is a small area of the retina at the back of the eye made up of specialist cells which process central vision as well as the fine detail of what we see.

Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good
Tom Bremridge
Macular Disease Society

People with macular degeneration rarely go totally blind but even those with a relatively mild version of the disease cannot drive and have difficulty reading, recognising faces and watching television.

But studies show people can be taught to use their peripheral vision to fill in the gaps, using "eccentric viewing" and "steady eye techniques".

When someone with central vision loss looks directly at an object it may disappear, go faint, blur or distort. But when they look above, below or to one side of it, they see it more clearly.

Blind spots

Eccentric viewing helps people find exactly where to focus their gaze to make their vision better.

Once this position is identified, they can be taught how to read again using the steady eye technique.

Instead of moving the eyes from left to right to read a sentence, the person should keep their eyes completely still and move the text to the left so that each word in turn moves into the area of best vision.

All UK patients with central vision loss should have the opportunity to try eccentric viewing
Mr Winfried Amoaku
Royal College of Ophthalmologists

Macular Disease Society chief executive Tom Bremridge said: "Eccentric viewing works by making the most of vision that remains.

"Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good.

"We have 86 volunteer trainers, all with central vision loss themselves, who have trained more than 310 people in their own communities, and our waiting list of nearly 1,200 people grows every day.

"We are keen that other service providers - social services, private practitioners and primary care trusts - now take up the baton."

Mr Winfried Amoaku, of the Royal College of Ophthalmologists, said eccentric viewing could help some patients with central vision loss "cope with everyday tasks such as identifying coins while out shopping, watching television and reading".

"The trouble is, we don't know who will benefit until they have tried the training.

"All UK patients with central vision loss should have the opportunity to try eccentric viewing techniques to see if they can benefit," he said.

Marek Karas, of the Royal National Institute of Blind People, also supported the research advances.

"Although there is still ongoing discussion among experts over the best form of training for this type of therapy, we welcome with interest these latest developments."

Between 25 and 30 million people worldwide have macular degeneration. But as the population ages, this figure will rise.

It is estimated that the number of people affected will triple by 2025.

FDA Approval Recommended for Implantable Macular Degeneration Device

2009-04-05T06:27:00.001-07:00

FDA Approval Recommended for Implantable Macular Degeneration Device
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 30, 2009

GAITHERSBURG, Md., March 30 -- An FDA advisory panel agreed that the agency should approve a miniature implantable telescope to improve central vision in elderly people with end-stage age-related macular degeneration.

The Ophthalmic Devices Panel voted unanimously Friday to recommend approval for the Implantable Miniature Telescope, made by Vision Care Ophthalmic Technologies, for use in patients who are 65 or older.

The thumbs-up came despite the device's association with loss of corneal cells over time.

Many elderly people would likely choose the telescope -- which could help maintain their ability to carry out daily tasks such as recognizing faces and reading books -- even if it meant developing corneal edema four or five years down the road, the panel decided.

Four years after the implant, about 15% of patients will have a significant depletion in endothelial cells, which can lead to corneal edema, according to an estimate by the panel's biostatistician, Karen Bandeen-Roche, Ph.D., of Johns Hopkins University in Baltimore.

The telescope works by directing light from the lens onto still-functioning portions of the macula to maintain central sight. It increases vision up to about three meters, helping patients perform close-up tasks, though doing nothing for their ability to drive.

The device would be implanted in one eye, after patients wear an external version for a few days to get a feel for it. Because it only improves central vision, implant recipients would rely on the opposite eye for peripheral sight.

The outcome of the Friday meeting was a major victory for the Vision Care, especially because the FDA turned down its original application in 2006 because of safety concerns.

New, longer-term data convinced the panel that the telescope can deliver improved vision for certain patients and that the associated cell loss is an acceptable risk.

Vision Care applied for a much narrower indication this time around. So narrow, in fact, that only about one-quarter of the participants included in the company's original trial would meet the new criteria, according to Henry Hudson, M.D., an vitreoretinal specialist in Tucson, Ariz., and lead investigator of the main clinical study submitted to the FDA.

The device was originally intended for patients 55 and older, but the sponsors bumped the age requirement up to 65. The new application also excludes patients with corneal guttata, and those who have an anterior chamber depth of less than 3 mm. Patients must also have retinal cell counts that are normal for their age group before receiving the implant.

The application calls for the device to be implanted by cornea specialists who are trained by Vision Care.

The panel's approval was based largely on a trial involving 206 patients with incurable central vision disorders and who were over 55 and had a need for cataract surgery.

The primary endpoint for efficacy was improvement of two lines or greater in either near or distance vision, which was achieved in 86% of patients at follow-up.

In a four-year follow-up that the company completed at the request of the FDA, 68% of the patients achieved a two-line or greater gain in either long distance or near vision four years after the surgery.

The panel heard from three octogenarians who said that if it weren't for their implantable telescopes, they would not be able to read books, make crafts, recognize their grandchildren, or carry out daily chores.

The committee suggested that the original trial cohort -- of which 130 are alive and still have the implant -- be followed for additional five years to monitor for complications such as rates of corneal transplant, retinal detachments and corneal edema.

The committee, chaired by Jayne Weiss, M.D., an ophthalmologist from the Kresge Eye Institute in Detroit, also said patients should be informed of the risk of cell loss and the possible benefits of improved central vision associated with the device.

The lead researcher agreed.

"The key consideration is proper patient expectation to get the maximum effect of this technology," Dr. Hudson said.

Positive Results from Neurotech's NT-501 Phase 2 Dry AMD

2009-03-30T04:33:00.001-07:00

Positive Results from Neurotech's NT-501 Phase 2 Dry AMD (Geographic Atrophy) Study Demonstrate Proof of Concept

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LINCOLN, R.I.--(BUSINESS WIRE)--Mar 26, 2009 - Neurotech Pharmaceuticals, Inc., today announced that the Company's lead product candidate, NT-501, substantially slowed the loss of vision in a Phase 2 clinical trial in subjects with dry age-related macular degeneration (AMD) involving geographic atrophy (GA). GA is a condition that destroys sharp central vision, often resulting in serious vision loss to one or both eyes. There are currently no approved treatments for dry AMD. In the study, the high dose of NT-501 stabilized best corrected visual acuity (BCVA) at 12-months, with 96.3% (p=0.078) of treated-patients losing fewer than three lines of vision, or 15 letters, versus 75% of the patients in the sham-treatment group.

NT-501 is an intraocular implant that consists of human cells that have been genetically modified to secrete ciliary neurotrophic factor (CNTF). CNTF is delivered directly to the back of the eye in a controlled, continuous basis by means of the Company's proprietary Encapsulated Cell Technology (ECT) platform, thereby bypassing the blood-retinal barrier and overcoming a major obstacle in the treatment of retinal disease.

The Phase 2 study is a multi-centered, randomized, double-masked, sham-controlled study of 51 subjects with GA. Patients received either a high or low dose NT-501 implant or a sham treatment in one eye only and were assessed for changes in BCVA. BCVA was measured by an Electronic Visual Acuity Tester (EVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Patients were also evaluated for an increase in BCVA. However, no increase was observed, likely due to existing photoreceptor damage. There were no NT-501 associated serious adverse events reported and both NT-501 and the surgical procedure were well-tolerated.

“The favorable functional visual acuity results for patients at this advanced stage of dry AMD are particularly promising due to the significant prevalence of the condition, its serious impact on quality of life and the current unmet medical need for effective therapy," stated Dr. George A. Williams, a study investigator and Professor and Chair of the Department of Ophthalmology at William Beaumont Hospital and the Oakland University William Beaumont School of Medicine in Royal Oak, MI.

The strong trend in visual acuity stabilization at 12 months was preceded by a dose-dependent, statistically significant (p<0.001 and p=0.013 for high and low dose, respectively) increase in retinal thickness as measured by optical coherence tomography (OCT) that was observed as early as 4 months post-implantation. The observed structural change is consistent with preclinical studies of NT-501 in which CNTF was shown to increase the thickness of the retina and the outer nuclear layer of photoreceptors responsible for vision. This increase in retinal thickness may be responsible for photoreceptor rescue and protection as observed in numerous animal models of retinal degeneration.

“Based on the increase in retinal thickness observed in this study it appears that CNTF may be exhibiting a biological effect on retinal photoreceptors as has been observed previously in animal studies,” said Dr. Paul Sieving, Director of the National Eye Institute and Principal Investigator of Neurotech's Phase 1 study of NT-501 in retinitis pigmentosa.

“We believe the anatomical changes observed in patients treated with NT-501 have led to the emergence of a clinically meaningful visual acuity benefit for patients with geographic atrophy,” commented Ted Danse, President and Chief Executive Officer of Neurotech. “NT-501 may provide a much needed treatment option for these patients and we intend to discuss these data and a pivotal trial design with the FDA.”

“We are very pleased that the outcome of this trial has shown such promise for patients with dry AMD involving geographic atrophy and are proud of our long-term support for this unique, breakthrough technology,” stated Stephen Rose, PhD, Chief Research Officer, Foundation Fighting Blindness.

Five devices from this trial have been explanted 12 months following implantation and all have been found to have uniformly healthy, viable cells that continue to produce therapeutic levels of CNTF. This is consistent with data from multiple trials of NT-501 in which, to date, 23 devices have been explanted between 12 and 18 months following implantation and all devices have contained healthy, viable CNTF-producing cells.

“We also believe the positive results of this study and long-term cell viability validate our ECT platform and support a breakthrough opportunity to advance long-term, well-tolerated treatments for patients facing chronic sight-stealing retinal diseases. As such, we are developing our second product utilizing the ECT platform to address a well-validated target, anti-VEGF therapy for wet AMD, that has the potential to provide a one-time administration for a 12 to 18 month period versus the current wet AMD treatment regimen that requires monthly injections with routine patient monitoring,” concluded Danse.

Data from the Phase 2 dry AMD/GA trial will be presented at the Retinal Physician Symposium on March 27, 2009 in the Bahamas, at IBC's 5th International Ocular Angiogenesis & Retinal Degeneration conference on March 31, 2009 in Las Vegas, at the Advanced Vitreoretinal Techniques and Technologies meeting on April 24, 2009 in Las Vegas and at the Association for Research in Vision and Ophthalmology (ARVO) meeting on May 6, 2009 in Ft. Lauderdale.

About Dry AMD/Geographic Atrophy

Age-related macular degeneration (AMD) is a chronic progressive disease of the macula that results in the loss of central vision. It is the leading cause of blindness in elderly people in the developed world. There are two forms of AMD•dry and wet. Dry AMD is the most common form of AMD representing approximately 90% of all AMD cases. In its advanced stages dry AMD can lead to the degeneration of photoreceptors and retinal pigment epithelial cells, a chronic condition called geographic atrophy (GA). There are currently no approved GA therapies for the nearly 1 million individuals affected in the United States.

About NT-501

Neurotech's lead product, NT-501, consists of encapsulated human cells genetically modified to secrete ciliary neurotrophic factor (CNTF). CNTF is a growth factor capable of rescuing dying photoreceptors and protecting them from degeneration. NT-501 is designed to continually deliver a therapeutic dose of CNTF into the back of the eye.

About Encapsulated Cell Technology

Neurotech's core technology platform is Encapsulated Cell Technology (ECT), a unique technology that allows for the long-term, sustained delivery of therapeutic factors to the back of the eye. ECT implants consist of cells that have been genetically modified to produce a specific therapeutic protein and are encapsulated in a semi-permeable hollow fiber membrane. The diffusive characteristics of the hollow fiber membrane are designed to promote long-term cell survival by allowing the influx of oxygen and nutrients while simultaneously preventing direct contact of the encapsulated cells with the cellular and molecular elements of the immune system. The cells continuously produce the therapeutic protein which diffuses out of the implant at the target site. ECT thereby enables the controlled, continuous delivery of therapeutic factors directly to the retina, bypassing the blood-retina barrier.

About Neurotech Pharmaceuticals, Inc.

Neurotech is developing sight-saving therapeutics for the treatment of chronic retinal diseases. The Company's lead product candidate, NT-501, is currently in late-stage clinical development for advanced dry age-related macular degeneration (dry AMD) and retinitis pigmentosa (RP). The Company's portfolio of product candidates also includes treatments for wet AMD. All of Neurotech's development programs are based on the Company's proprietary Encapsulated Cell Technology (ECT). ECT uniquely enables the controlled, continuous delivery of biologics directly to the back of the eye, thereby overcoming a major obstacle in the treatment of retinal disease. To learn more, please visit our web site at www.neurotechusa.com.

Macular degeneration may have same biomarker as kidney function

2009-03-21T07:31:00.001-07:00

Macular degeneration may have same biomarker as kidney function
Publish date: Mar 5, 2009
Source:Optamology Times

Madison, WI—Cystatin C, a biomarker of kidney function, also may be associated with the incidence of age-related macular degeneration (AMD), said researchers.

Adjusted analyses found that serum levels of the protein were associated with the incidence of both early and exudative AMD, according to Ronald Klein, MD, MPH, and colleagues.

There was an association between chronic kidney disease and macular degeneration, but the association between cystatin C and the degenerative eye disease was intensified in patients without chronic kidney disease.

"This suggests that this relationship might not be due to kidney-related processes," the researchers said.

Studies on the relationship of kidney disease and AMD have been few and inconsistent, so researchers conducted a prospective cohort study of 4,926 patients aged 43 to 86 years, in Beaver Dam, WI.

Pill Shows Promise for Treatment of Macular Degeneration

2009-03-14T06:17:00.000-07:00

By JEAN ENERSEN / KING 5 News

Beatrice Dean has had the dry form of macular degeneration for 20 years.

"You get to the point where you don't read any longer, you don't write, you just don't see things straight on,” she said.

A National Institute of Health study found that certain eye vitamins can help, to a point. Dr Richard Bensinger of Swedish Medical Center says this was the first breakthrough.

"It showed a very significant slowing of the condition, not a cure, or stoppage,” he said.

Now the Acucela biotech firm in Bothell is working on a pill that may finally stop the disease altogether.

Founder Ryo Kubota says the goal is to prevent dry form from progressing into the more severe wet form, which can cause blindness overnight.

"Primarily it will be preventative and slow down the disease, but in animal test studies that we've done, we've show in can reduce the already accumulated toxic byproducts,” said Dr. Kubota.

In theory, the drug works by blocking the damage before it starts.

Who will get macular degeneration?

"There really is no risk factor that's known except for everybody's favorite, smoking,” said Dr. Kubota.

Dr. Kobota hopes this research will make all the difference since macular degeneration cases are expected to rise as baby boomers get older.

“We're hoping this drug to be on the market in five to 10 years,” he said.

Human trials are just beginning. We'll keep you up to date on the research and when the study will begin recruiting locally.

Brain Adapts to Age-Related Eye Disease

2009-03-07T11:08:00.000-08:00

Brain Adapts to Age-Related Eye Disease
Neurons seek input from undamaged areas to compensate, study finds

Posted March 3, 2009

TUESDAY, March 3 (HealthDay News) -- When macular degeneration causes one to start losing his or her sight, the affected neurons simply start seeking visual input from other, non-affected parts of the eye, Massachusetts Institute of Technology researchers report.

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"This study shows us one way that the brain changes when its inputs change. Neurons seem to want to receive input: When their usual input disappears, they start responding to the next best thing," senior author Nancy Kanwisher, of MIT's McGovern Institute for Brain Research, said in an university news release.

The researchers found when the cells in the fovea, the part of the retina responsible for the central field of vision, were damaged by macular degeneration (MD) -- the neuron attached to them begin responding to stimuli in an undamaged section -- a type of internal reorganization of the eye's visual map as opposed to the cortex's work being shifting to other neurons.

"Our study shows that the changes we see in neural response in people with MD are probably driven by the lack of input to a population of neurons, not by a change in visual information-processing strategy," Kanwisher said.

The findings are published in the March 4 issue of the Journal of Neuroscience.

Macular degeneration, the most common form of adult blindness, affects almost 2 million people in the United States. Patients often compensate for lack of central vision by rolling their eyes upward so they can utilize the preferred retinal locus (PRL), an undamaged area under and adjacent to the affected part of the retina.

"Macular degeneration is a great opportunity to learn more about plasticity in the adult cortex," Kanwisher said.

Should everyone with AMD be taking high-dose vitamins?

2009-02-25T11:38:00.001-08:00

Only those patients with intermediate to advanced forms of AMD should be taking the high-dose multivitamin formula. Ask your doctor if you should be taking this vitamin supplement.

Is it safe to take high doses of vitamin E?

AREDS researchers say it is unclear if the possible increased risk associated with very high doses - 500IU to 2000IU - of vitamin E applies to people taking 400IU. An increased risk of mortality was not found among those taking about 400IU of vitamin E.

The National Institutes of Health Office of Dietary Supplements has a fact sheet on vitamin E that summarizes the research on vitamin E and different chronic diseases.

Will vitamins make my vision better?

2009-02-17T16:39:00.000-08:00

Will vitamins make my vision better?

Vitamin therapy for AMD will help slow the progression of AMD. Vitamins are not a cure for AMD and will not give back any vision that has already been lost.

Should everyone with AMD be taking high-dose vitamins?

Only those patients with intermediate to advanced forms of AMD should be taking the high-dose multivitamin formula. Ask your doctor if you should be taking this vitamin supplement.

Vitamins and AMD

2009-02-12T09:06:00.000-08:00

Are vitamins helpful for AMD?

The Age-Related Eye Disease Study (AREDS) showed that taking high-dose anti-oxidant vitamins and zinc significantly slowed the rate of progression of vision loss in patients who had more advanced forms of AMD.

AREDS II is an ongoing study to understand the role of certain other vitamins. More information

What vitamins should I take?

The following vitamin combination was proven effective in the AREDS study:

* Vitamin C, 500 mg
* Vitamin E, 400 IU
* Beta-Carotene, 15 mg
* Zinc, as zinc oxide, 80 mg
* Copper, as cupric oxide, 2 mg

Vision Loss from Macular Degeneration

2009-02-05T20:30:00.000-08:00

By Jacob Teitelbaum, MD on January 30, 2009 in Complementary Medicine

Does the center of your visual field seemed blurred?

Age-Related Macular Degeneration (ARMD) is the most common cause of age related vision loss (besides needing reading glasses). Fortunately, natural treatments are very helpful for both prevention and treatment.

BACKGROUND

The macula is in the central part of the retina that is used for more detailed vision, so it tends to affect the center of our visual field. As it has the largest concentration of cells, it also needs more oxygen then the rest of the retina. ARMD is a degenerative condition of the macula. It is the most common cause of vision loss in the United States in those 50 or older, and increases with age. ARMD is caused by hardening of the arteries that nourish the retina. Fortunately, macular degeneration does not cause total blindness since it does not affect the peripheral vision.

There are 2 types of ARMD:

Wet ARMD

Around 10% of cases are called "Wet" ARMD, as new, but fragile, blood vessels try to regrow in to support the macula. These fragile new vessels sometimes leak (hence the name "Wet") causing rapid vision loss in the center of 1 eye.

Dry ARMD

The other 90% of cases are called "Dry" ARMD, and these have a very gradual progression.

PREVENTION and TREATMENT

A number of studies have shown that good nutrition can slow or prevent the development of macular degeneration. For example, it has been proven that people with diets high in antioxidant containing fruits and vegetables (especially leafy green vegetables and colorful berries) have a lower incidence of macular degeneration. This is associated with high levels of the nutrient flavonoids, as well as lutein and zeaxanthin (both found in egg yolks), and lycopene (in tomatoes). In fact, those with high levels of these nutrients had only half the risk of ARMD. Fish oils and nuts were also very protective. Red wine is protective, but beer can worsen ARMD.

Research suggests that a mix of nutrients is more effective than individual ones for ARMD. I recommend a product called "Ocudyne II" capsules by Nutricology (easily found in many online shops) along with:

* Vitamin C 1,000 mg 2-3x day
* Vitamin E (must be natural and mixed tocopherols) 600 units/day
* Selenium 200 mcg a day
* Ginkgo Biloba (standardized to 24%) 40-80 mg 3x day
* Bilberry extract (25% extract) 40-80 mg 3x day
* Zinc 25-50 mg a day
* Eat fish (especially tuna or salmon at least 2x week) ot take fish oil

Other helpful tips include:

* Protect your eyes with sunglasses that have UV protection. Ultraviolet rays are believed to cause damage to the pigment cells in the retina.
* Quit smoking. Smoking worsens circulation to the retinal blood vessels.

To make reading easier:

* Use a halogen light. These have less glare than standard light bulbs.
* Shine the light directly on your reading material. This improves the contrast and makes the print easier to see.
* Use a hand-held magnifier. A cheap drugstore magnifier can increase the print size dramatically.

For wet ARMD, your eye doctor may recommend laser treatments, which can be added to the treatments above.

Researchers Hope to Mime 1000 Neurons With High-Res Artificial Retina

2009-01-28T09:54:00.000-08:00

By Sally Adee

19 December 2008—Researchers from three major California universities are working on an artificial retina that could give limited sight to people with degenerative diseases of the retina, such as macular degeneration. Such a prosthesis is a more realistic future treatment than stem-cell therapy, gene therapy, or eye transplants, its developers say. The Californian researchers have been treating people using a 60-pixel retina in a clinical trial for two years. But they are now gunning for a system with a resolution of 1000 pixels, they reported Tuesday at the IEEE International Electron Devices Meeting (IEDM), in San Francisco. And in contrast with systems in trials today, the researchers hope to develop a system that would be completely sealed into the eye, without any external components.  

James Weiland, an associate professor of ophthalmology at the University of Southern California’s Biomimetic MicroElectronic Systems (BMES) Engineering Research Center, reported on an experimental system that includes a 1000-pixel test chip. He expects to have the high-res retina at a point where they can begin clinical trials in about five years. 

In the artificial retina, a camera mounted on glasses outside the eye sends the visual signals to two RF coils inside the front half of the eye. An electronics module inside the eye’s vitreous humor—the gelatinous saline sac that fills the space between the lens of the eye and the retina at the back of the eye—translates the RF signals into voltages for use in the high-res retina chip. Lying against the retina is a grid of 1000 electrodes on a flexible substrate; these electrodes apply voltage signals to the retina, which interprets them as photons. The rest of the visual process takes place as usual, and the system mimics relatively normal vision. 

The group, which includes researchers from the BMES center, the California Institute of Technology, in Pasadena, and the University of California, Santa Cruz, which developed earlier prototypes in collaboration with Second Sight Medical Products. The first was the Argus 16, with 16 electrodes; the next, Argus II, has 60. Both have been in clinical trials. The Argus II implant enabled blind clinical-test subjects to follow a straight line for about 6 meters without deviating from the path. But the key to a medical device’s ability to grant true independence is whether it allows the person to identify faces or read. Artificial-eye researchers estimate that such tasks will require between 600 and 1000 electrodes. 

Ideally, that artificial retina would be contained entirely within a person’s eyeball. In order to create a fully self-contained high-resolution system, the team must consider many different pieces: a parylene coating to protect the prosthesis from the corrosive effects of being inside the body for 60 years or more, a flexible substrate that can conform to the idiosyncracies of different individuals’ retinal curves, and, most important, wireless power.  

Instead of batteries, the device uses inductive coils that pick up energy transmitted from outside the body. The researchers are also relying on insights from MEMS fabrication: the implant coils, interconnects, and 1000 electrodes are formed during a single parylene micromachining process. 

“This is a really breathtaking system,” says MIT electrical engineering professor Jesus del Alamo, who organized the panel at IEDM where Weiland discussed the group’s research. “They have every piece of the system in place—they have even designed their own software.”  

But there is more work to be done. “You need to get everything into the eye,” says Jamal Deen, a professor of electrical and computer engineering at McMaster University, in Ontario, “including the camera.” 

So far, the camera, image-processing hardware, power amplifier, and data modulator are external, but Weiland hopes to implant even the camera part of the system by fixing it to the lens of the eye. His collaborators at USC are working on miniaturizing the camera system so that it can be placed onto the lens in a routine surgical procedure similar to cataract surgery. “If we can make a camera the size of the lens, we can implant it there,” he says. “But again, the challenge is making a self-contained camera without a larger control circuit.” 

He cautions that it will take several years to put the whole system together and start clinical trials. But those trials will lean heavily on what is learned from trials of the implant being tested today. So potential patients should not wait for the new chip. “The 1000-channel device is likely more than five years away from even starting clinical testing,” says Weiland. “In the meantime, our 60-channel device has been in clinical trials for over two years, and sometimes we run into difficulty recruiting for the trial because some prospective participants are aware of the research efforts on higher-channel-count devices.” 

Brain Reorganizes to Adjust for Vision Loss in Macular Degeneration

2009-01-24T16:13:00.000-08:00

Published by Karin

A new study shows that when people with retinal disease such as macular degeneration use a peripheral part of their retina to compensate for their loss of central vision, their brain appears to compensate by reorganizing its neural connections.

Macular degeneration (MD) causes a progressive loss of central visual. To cope with this, MD patients often start to focus using a functional retinal area in the periphery of their area of vision. This use of a new area of focus may foster cortical reorganization.

Scientists at the Georgia Institute of Technology used functional magnetic resonance imaging (fMRI) to measure brain activity in participants as they performed a series of tests designed to visually stimulate their peripheral regions. It was determined that when the participants visually stimulated the peripheral retinal locations they increased brain activity in the same areas of the visual cortex that are normally activated when healthy patients focused on objects in their central visual field.

Study authors believe that large-scale cortical reorganization of visual processing occurs in humans in response to retinal disease. While several other studies have suggested that the brain can reorganize itself, this is the first study to show that this reorganization in patients with retinal disease is related to patient behavior.

Researchers are currently analyzing how long this reorganization takes and whether it can be assisted with low-vision training.

Learn more about macular degeneration

Read about eye exercises for vision fitness

SOURCE: Reorganization of visual processing is related to eccentric viewing in patients with macular degeneration, Schumacher, et al, Restorative Neurology and Neuroscience, Volume 26, Number 4-5, 2008, 391 – 402.

MacuCLEAR and Mystic Pharmaceuticals Agree To Collaborate on Macular Degeneration Phase I/II Clinical Trial

2009-01-14T10:46:00.000-08:00

PLANO, Texas--(BUSINESS WIRE)--MacuCLEAR, Inc. (“MacuCLEAR”) announced today it has entered into a collaborative business relationship with Mystic Pharmaceuticals Inc. for its upcoming Phase I/II Human Clinical Trials. MacuCLEAR is developing MC 1101, for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). Mystic Pharmaceuticals, Inc. (“Mystic”) has developed a novel unit dose drug delivery platform capable of preservative free, precision delivery of ophthalmic drugs.

“We believe Mystic’s novel VersiDoser™ delivery system will help overcome many of the challenges of topical delivery of ophthalmic drugs to the eye,” said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. “Standard eyedroppers typically deliver too large a drop that 'floods' the eye. Conventional eyedroppers waste product and are difficult for elderly patients to use reliably on a daily basis. Mystic’s individually packaged drops can be precisely sized and accurately delivered with a unique dispenser that is easy to use.” Ralston added, “The Mystic dispenser counts the drops delivered, which will be helpful in tracking compliance and accounting for the usage of a reimbursed product.”

Mystic Pharmaceuticals’ President and CEO, Timothy Sullivan, stated, “We are pleased to work with MacuCLEAR in their clinical program. Their drug has shown promise throughout its preclinical program and has received fast track status from the FDA. AMD is a growing healthcare problem for our aging population. Our delivery systems are uniquely designed to safely and effectively deliver drugs to low vision and elderly people. The combination of these two technologies offers great potential for addressing a terrible disease resulting in loss of vision.”

Ralston and Sullivan jointly announced the collaboration at the OneMedPlace Emerging Healthcare Technologies Finance Forum at the Drake Hotel in San Francisco today.

About MacuCLEAR: MacuCLEAR, Inc. is a specialty pharmaceutical development company, based in Plano, Texas. Its lead compound, MC1101 is a novel, topically delivered solution for the treatment and prevention of the progression of the Dry or early stage of age related macular degeneration, which afflicts 90% of all who have AMD. This technology was invented at Texas A&M University by George C.Y. Chiou, PhD, who led the development of Timolol, a pioneering treatment for glaucoma.

For more information please visit the MacuCLEAR website: www.macuclear.com

About Mystic Pharmaceuticals, Inc.

Mystic Pharmaceuticals™ is an integrated specialty pharmaceutical company based in Austin, Texas. Mystic develops precision unit dose ophthalmic and intranasal drug delivery platforms for pharmaceuticals, biopharmaceuticals and vaccines. Mystic combines its novel drug delivery systems with a pipeline of pharmaceuticals and biologics under development by Mystic or its partners, to meet the expanding global market demand for medications which are lower cost, safer and easier to use for consumers.

For more information please visit the Mystic website: www.mysticpharmaceuticals.com

Wet AMD? Participants Needed Now for New Macular Degeneration Treatment Trials.

2009-01-09T12:53:00.000-08:00

A new trial has just begun comparing the two Macular Degeneration Wet drugs, Avastin and Lucentis. Currently Lucentis is the FDA approved drug and Avastin has off-label approval. The trial seeks to compare the two drugs for safety and effectiveness. Participants are being recruited now.

January 5, 2009 (FPRC) --
The US National Eye Institute has announced a new trial into the treatment of Macular Degeneration Wet.

Although the condition is generally accepted as incurable, eye doctors have had good results in delaying the worst of the symptoms, including full blindness, by injecting drugs directly into the eyes of patients.

Currently Lucentis is the FDA approved drug for wet macular degeneration treatment. It was approved in June 2006.

Years of clinical trials showed that with repeated treatment, Lucentis slowed the progression of vision loss and in some cases even improved vision.

One of the problems with Lucentis is that it is a very expensive drug, costing approximately $2000 per injection.

Injections are usually needed every 4 weeks.

Avastin, a much cheaper drug, has off-label approval for treating wet AMD. It was approved by the FDA in 2004 for colon cancer treatment.

Avastin works in a similar way to Lucentis by stopping the unwanted blood vessel growth present in wet AMD.

The Lucentis-Avastin trial will compare the two drugs for safety and effectiveness.

Participants in the trial can expect to be treated with an injection of either drug every four weeks for up to two years.

It is important to remember that wet macular degeneration is generally regarded as incurable.

Also participants in the trial should be aware that possible side effects of eye injection treatment could include eye inflammation and increased eye pressure athough serious side effects are rare.

Macular Degeneration is a leading cause of age related blindness. The good news is that
age related eye disease and eventual blindness CAN be prevented. Specific nutrients, reduction of risk factors and early detection can save your sight.

To learn more about prevention and how to participate in the
Lucentis-Avastin Trial visit our website.
http://maculardegenerationtreatmenttips.com/

The Many Uses of CoenzymeQ10

2009-01-03T10:48:00.000-08:00

The benefits of coenzyme Q10 have mostly been ascribed to aiding heart health in recent years. In this regard, it is known as a nutrient that may help patients who suffer from congestive heart failure.

It has also been touted by many natural health experts who point out that statin prescription drugs — which are used to lower cholesterol — also deplete the body of essential coenzyme Q10. Therefore, supplementing with coenzyme Q10 is particuarly important for statin users.

In Japan, Coenzyme Q10 is a hugely popular supplement and a significant percentage of the adult population uses it as a general anti-aging supplement.

But beyond these now well known facts, the latest research is indicating coenzyme Q10 has many other uses.

What is Coenzyme Q10 Used For

The efficacy of coenzyme Q10 in migraines is just one of the latest uses for this potent nutrient.

In the February 2005 issue of Neurology, a study was referenced that took place in Switzerland in which Coenzyme Q10 supplemention reduced migraine frequency by 27% in sufferers of this condition.

This study was not conducted with a large number of patients–only 42 people–and so further research is needed in this area, but the initial efficacy of coenzyme Q10 in migraines is off to a promising start.

Another of the recent benefits of coenzyme Q10 is this nutrient’s role in possibly slowing down macular degeneration in its early stages. This is fantastic news because age-related macular degneration is the leading cause of vision loss in adults over 60.

Some of this research was reported in the 2005 May Opthamologica journal, although it was found that other nutrients can also help improve age-related macular degeneration as well, such as acetly-L carnitine and omega-3 fatty acids.

Before this, other research has shown that lutein and zeaxanthin are two important nutrients for the eyes and macular degeneration as well.

The benefits of coenzyme Q10 is now also extending into cancer. It’s been reported that cancer sufferers often have low levels of this nutrient.

Therefore, research has been conducted to see if coenzyme Q10 supplementation would improve certain types of cancer because one of the functions of this nutrient is to boost the body’s immune response.

So far, the research on coenzyme Q10 is showing that when it is combined with other antioxidants such as vitamin C, E, beta carotene, the mineral selenium, and Omega 3 fatty acids, it may help patients with breast cancer. More studies need to be conducted to confirm these initial findings.

The last of the recent benefits of coenzyme Q10 indicate it may be helpful in fighting the progression of neurodegenerative diseases such as Parkinson’s. In fact, promising results were reported in the Archives of Neurology, in which patients in one study experienced a 44% less decline in mental function and movement as opposed to those who took placebo.

This was a government funded study by the National Institute of Neurological Disorders, which is a part of the larger National Institutes of Health.

As promising as all of these recent studies are, the good news is that coenzyme Q10 is also being studied for many other health conditions as well, ranging from male fertility, alleviating diabetic complications, improving memory, and much more.

Talk to a natural health expert for tips on choosing a quality coenzyme Q10 supplement — or any other promising supplement you wish to investigate.

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Pioneering Eye Surgeon Sees Hope for Treating Macular Degeneration with Natural Hormones

2008-12-27T20:25:00.000-08:00

By Debora Yost

Plant caroteinoids such as lutein and zeaxanthin were long ago shown to help prevent macular degeneration. But is there more that can be done to protect against this epidemic of blindness?

George W. Rozakis, MD is a Cornell-trained biomedical engineer specializing in laser eye surgery and lens implants. A pioneer in the field of LASIK surgery,1 Dr. Rozakis is now vigorously involved in anti-aging medical research.

Dr. Rozakis is focusing on a potential breakthrough in treating macular degeneration, a condition that gradually destroys central vision. Also called age-related macular degeneration, it is the leading cause of blindness in people aged 65 and older.

Dr. Rozakis believes that restoring the correct balance of natural hormones that decline with age can retard and possibly even reverse the progression of macular degeneration. To investigate this hypothesis, he is setting up a long-term study and is currently seeking subjects to participate in the trial.
Hormones and Your Vision

The hormonal link with macular degeneration began to evolve when Dr. Rozakis met another medical pioneer, Sergey A. Dzugan, MD, PhD, during a conference in Chicago four years ago. Dr. Dzugan is a cardiovascular surgeon and internationally known expert in anti-aging and hormonal medicine.

“Dr. Dzugan has done numerous studies2-4 and written numerous articles on the association between low hormone levels and multiple disease states, including the problem of atherosclerosis and cholesterol elevation,” says Dr. Rozakis. “As an ophthalmologist I was impressed by the evidence that restoring and optimizing levels of key hormones improve brain function, largely because the retina is part of the brain. For example, there is very impressive literature that testosterone slows down the progression of Alzheimer’s disease.5 Pregnenolone is extremely important for the brain and nervous system, as are progesterone and estrogens. Women whose progesterone levels drop develop negative personality changes.6 In animal models, pregnenolone and DHEA have been shown to profoundly stimulate the healing of neurologic injury.7-9 Women who enter into menopause at a young age develop macular degeneration, presumably because of the absence of estrogens.10,11 Blocking estrogens with the anti-cancer drug tamoxifen is harmful to the retina.12 This leads us to wonder if optimal hormonal health also positively impacts ocular health.”

“When an article appeared in the American Journal of Ophthalmology indicating that DHEA, or dehydroepiandrosterone, is exceptionally low in macular degeneration patients,13 I was shocked and excited,” says Dr. Rozakis. This finding provided a major clue that hormonal imbalance was part of the problem of macular degeneration.

“DHEA is like the Grand Central Station of hormone chemistry,” says Dr. Rozakis. “When DHEA levels drop, it strongly implies that levels of other hormones such as pregnenolone, estrogens, and testosterone are out of balance or suboptimal.” All of these hormones make the body thrive—they give us virility, fertility, and help us act and react quicker. Since the retina contains hormone receptors, hormones must be part of the biophysiology of vision itself.
Cardiovascular Link

Low DHEA levels in macular degeneration could also explain its association with heart disease, as it is known that macular degeneration is an independent risk factor for stroke and coronary artery disease. In a study conducted by Australian scientists,14 macular degeneration predicted a five-fold higher risk of cardiovascular mortality and a 10-fold higher risk of stroke mortality. After controlling for traditional cardiovascular risk factors, age-related macular degeneration predicted a doubling of cardiovascular mortality. Since hormone deficiency has been linked with both heart disease and eye disorders,13,15 it is a prime suspect that links the heart to the eye.

Further examination of the literature reveals a major review article from Italy that explains the importance of hormones to the retina.16 In this article, it is shown that the retina is able to attempt to make its own hormones, just like the brain. “The article also indicates that many of the hormones we use in anti-aging programs have a role in the retina, such as pregnenolone, DHEA, testosterone, estrogens, and progesterone. Few ophthalmologists and optometrists are aware of this relationship. This was the smoking gun that led to our hypothesis,” Dr. Rozakis notes.
Macular Degeneration and Cholesterol

A good theory needs to connect all the dots. Dr. Rozakis explains that one challenge in shaping his theory was explaining the presence of “drusen” or spots that appear in the retina in patients with macular degeneration. Many consider these spots to be “degradation products.”

Recently, Goldis Malek, PhD, and others17-19 found that cholesterol was present in those spots. This led some people to think that cholesterol-lowering agents, such as statins, might help macular degeneration—but they do not. In fact, there is concern that statins actually increase the risk of dry macular degeneration advancing to the neovascular form of the disease, whereby tiny blood vessels in the eye begin to bleed.20

Dr. Rozakis notes, “To Dr. Dzugan and me, the presence of cholesterol in the macula was the key piece of data that integrated everything. The presence of cholesterol in the macula suggests that the retina is trying to make hormones—but that it can’t. So, the body’s accumulation of cholesterol and drusen worsen.” He continues, “The macula can’t get the hormones it needs from the blood because there aren’t much there. As a result, if the macula is having trouble converting cholesterol into hormones, drusen form, and this results in the drusen we see in macular degeneration. Why the macula stops making hormones is unknown, but it is associated with aging. We can speculate that it happens because the enzymes which do the conversion decrease or are down-regulated with aging.”

“This same ‘story’ of cholesterol and hormones plays itself out in the body as a whole,” says Dr. Rozakis. “We do know that the adrenal gland, which produces DHEA, loses the ability to manufacture hormones as we age. As Dr. Dzugan published, this hormonal decline stimulates the liver to produce more cholesterol in an attempt to create more hormones.3 This is why restoring hormones to their normal levels causes the liver to produce less cholesterol. That same paradigm may be happening in the macula. This is the basis of our hypothesis. The goal therefore must be to provide the retina the hormones it needs through supplementation.”
Reviewing the Evidence

There is already evidence to support the notion that DHEA protects the eyes against oxidative damage21 and that the hormone pregnenolone improves electrical activity in the retina, as measured by the electroretinogram (ERG).22,23 There is also evidence to support the use of melatonin in the treatment of macular degeneration.24,25

The theory that optimizing hormones may help promote macular health is based on these scientific facts:

1.The macula, which is located in the center of the retina, uses hormones to function.16
2.The normal macula has the unique ability to make its own hormones.26
3.The bloodstream of patients with macular degeneration is deficient in hormones.11,13
4.Drusen—the tiny yellow abnormalities that appear behind the macula in individuals with macular degeneration—contain cholesterol.17-19
5.Age-related macular degeneration is related to cardiovascular mortality.14

Dr. Rozakis speculates that the solution for treating macular degeneration is to measure and restore age-depleted hormones to optimal levels so that the macula can absorb the hormones it needs from the blood. “Hopefully restoring hormones to their normal levels in the bloodstream will cause the macula to stop absorbing cholesterol and, as a result, drusen formation will hopefully decline,” says Dr. Rozakis. “We certainly need a better understanding of the pathophysiology of this blinding disease.”27
A Higher Level of Natural Treatment

Dr. Rozakis sees hormone restoration as a strategy to improve on existing studies showing that certain nutrients can reduce the progression of age-related macular degeneration. The long-term Age-Related Eye Disease Study (AREDS), conducted by the National Eye Institute, found that supplementing the anti-oxidants beta-carotene, vitamin C, vitamin E, and the mineral zinc reduced the risk of developing advanced states of macular degeneration in more than 4,700 high-risk patients aged 55 to 80 who were enrolled in the study.28

The specific amounts of nutrients used by the study researchers were:

*500 mg of vitamin C
*400 IU of vitamin E
*15 mg of beta-carotene
*80 mg of zinc
*2 mg of copper.

The copper, administered as cupric oxide, was included in the formula to prevent copper-deficiency anemia, which is associated with high zinc intake.

As a result of the AREDS trial, many ophthalmologists are recommending supplements containing the study’s recommended dosages for patients with or at a high risk for age-related macular degeneration.

Dr. Rozakis is currently developing his own study to test his theory concerning the relationship between low levels of DHEA and macular degeneration. “Our study is going to focus on overall hormonal balance and will include the supplements used in the AREDS study as well,” says Dr. Rozakis. “Our goal is to do everything we can to stop macular degeneration. The fact that hormones are much more powerful than vitamins holds hope that the results will be significant.”

If you have any questions on the scientific content of this article, please contact a Life Extension Health Advisor at 1-800-226-2370.

Macular Degeneration Can Disappear with Natural Therapies

2008-12-16T08:57:00.000-08:00

Filed Under Dr. Zoltan Rona (MD) |

Macular degeneration is the leading cause of visual loss in Europeans and North Americans over the age of 50. It is thought to be the direct result of free radical damage to the macula, a small area located at the centre of the retina. The macula is responsible for fine vision.

Patient Profile:

A 79-year-old woman recently consulted me because a top expert in eye diseases diagnosed her as having macular degeneration. She was told that nothing could be done and, to quote the specialist, “You are going to go blind.”

As it turns out, this was not only discouraging for my patient, but a completely wrong prediction.

Here’s the advice I gave this patient:

Diet

• Eat more legumes, which have a cleansing effect due to their high content of sulphur-containing amino acids.
• Consume more fresh fruits and vegetables, especially yellow vegetables.
• Berries are wonderful—particularly blueberries because of their high content of anthocyanidins.
• Cherries are valuable because they offer carotenes, flavonoids, and vitamins E and C.
• Carotenoids—lutein and zeaxanthin—are most strongly associated with reduced risk of macular degeneration. The best sources are spinach, kale, and collard greens.

Supplements

None of these natural supplements have any serious side effects. Take the following antioxidant supplements each day:

• Beta-carotene: 100,000 IU
• Green powder: Choose an enzymatically active green “superfood” powder. Green products are high in carotenoids. Take 1 tablespoon in 15 ml of water or juice.
• Vitamin C: 2,000 mg three times daily
• Pycnogenol: 300 mg (from either pine bark extract or grape seed extract)
• Coenzyme Q10: 100 mg three times daily
• Vitamin E: 400 IU three times daily
• Selenium: 600 mcg
• Zinc chelate or citrate: 100 mg. Several published studies support the use of zinc supplements to help reverse numerous eye disorders including macular degeneration.

Botanicals

Research reveals that the following botanical medicines also show impressive results with macular degeneration:

• Ginkgo biloba extract: 250 mg
• Bilberry extract: 80 mg twice daily (25% anthocyanidin content). Bilberry is used in Europe for cataracts, macular degeneration, retinitis pigmentosa, and diabetic retinopathy. It can also prevent further damage from glaucoma by working as an antioxidant in the eyes. Its anthocyanidins increase vitamin C levels (a critical nutrient for healthy eyes) within the cells and decrease capillary fragility.

Result

A six-month follow-up visit to the eye specialist showed complete clearing of this patient’s macular degeneration.

Dr. Zoltan Rona

Macular degeneration patients treated with cancer drug show problems

2008-12-12T19:54:00.000-08:00

Last Updated: Friday, December 5, 2008 | 10:21 AM ET

The Canadian Press

The colon cancer drug Avastin is used off-label to treat wet AMD. (CBC)

Public health authorities in Canada are investigating a spike in cases of eye inflammation among patients being treated for macular degeneration with the cancer drug Avastin.

First noticed in British Columbia, there appears to be a rise in cases in other parts of the country as well. And now authorities are trying to draw the potential problem to the attention of the global public health community in the hopes of seeing if it is being observed elsewhere.

The problem is believed to stem from a particular lot of the drug that was distributed widely around the world, though not to the United States. The lot number is B3002B028.

The drug's manufacturer, the Swiss pharmaceutical firm Roche, is co-operating with Health Canada and the British Columbia Centre for Disease Control, which was alerted to the problem by ophthalmologists.

The situation puts Roche in an awkward position. Avastin (bevacizumab) is a colon cancer drug; it is not approved for use as a treatment age-related macular degeneration.

And Roche doesn't want to encourage the off-label use of the drug by ophthalmologists who have embraced it as a much cheaper alternative to a similar drug, Lucentis, which has been approved as a treatment for macular degeneration.

"Absolutely we do not recommend this," said Samantha Ouimet, a spokesperson for Roche Canada. "They're taking it out of its [original] packaging, repackaging it and injecting it into people's eyes. This comes in a bag and it's meant for intravenous use for people with cancer."

Ouimet said the company is in discussions with Health Canada. But it is reluctant to put out an advisory warning people not to use the drug as a treatment for age-related macular degeneration when the drug was never approved for this purpose.

Any statement could be seen as promoting the off-label use, Ouimet said.

"Is it a delicate situation? Absolutely."

B.C. cluster investigated

Ophthamologists in British Columbia started noticing a problem in October. Under two per cent of people treated for age-related macular degeneration with Avastin will develop acute intra-ocular inflammation. But between Oct. 3 and Oct. 27, the rates were much higher.

The BC CDC was called in to help investigate the cluster of cases, and concluded the rate of inflammation among patients treated with Avastin from the lot in question was almost 10 times higher than the normal rate. The lot is no longer in use there.

Dr. David Patrick, the centre's director of epidemiology services, submitted a report on the investigation to ProMED, an electronic reporting system that sends out alerts about outbreaks to a mailing list of public health officials, scientists and other interested parties around the world.

No problems reported in other countries

Patrick said the team investigating the issue sent out feelers to ophthamologists in about a half-dozen other Canadian centres and has heard back that others too have noticed an increase in cases of inflammation after use.

The inflammation causes cloudy vision, but appears to clear up over time, he said.

Ouimet said there have been no reports of problems from other countries — and no reports of adverse reactions in cancer patients who received treatments from the same lot.

"We have reviewed all the analytical release data for the lot in question. And all the best parameters were within the limits for use in oncology," she said.

"So we found no deviations in the manufacturing process. All the environmental testing was fully compliant. We've revisited the batch. It is safe … for its indicated purpose."

Patrick said scientists at the University of British Columbia are studying vials of the drug, but haven't found anything usual.

"On the initial go-through they haven't determined a chemical difference between the implicated lot and another one. But there may well be further work with that," he said.

Treatment of Macular Degeneration Looks Promising After New Study

2008-12-09T08:46:00.000-08:00

It may now be possible to trigger the regeneration of inner nerve cells in a damaged mammalian retina, according to researchers from The University of Washington.

Writing about their findings in the Proceedings of the National Academy of Sciences, the researchers revealed that they studied a particular retinal cell called the Muller glia.

"This type of cell exists in all the retinas of all vertebrates, so the cellular source for regeneration is present in the human retina," said lead researcher Tom Reh, a professor of Biological Structure at the university.

He said that developing certain methods to re-generate such cells might lead to new treatments for vision loss from retina-damaging diseases, like macular degeneration.

The researchers pointed out that cold-blooded vertebrates like fish have a remarkable ability to regenerate their retinas after damage, while Birds that are warm-blooded have some limited ability to regenerate retinal nerve cells after exposure to nerve toxins.

While fish can generate all types of retinal nerve cells, the researcher said, chicks produce only a few types of retinal nerve cell replacements, and few receptors for detecting light.

After a baby's eyes pass a certain developmental stage, Muller glia cells generally stop dividing.

According to the researchers, damage to retinal cells in both fish and birds prompts the specialized Muller glia cells to start dividing again, and to increase their options by becoming a more general type of cell called a progenitor cell. They say that such progenitor cells can then turn into any of several types of specialized nerve cells.

The researchers say that mammals have an even more limited Muller glia cell response to injury, compared to birds. They suggest that in an injured mouse or rat retina, the cells may react and become larger, but few start dividing again.

The team points out that several research groups have tried to stimulate the Muller glia cells to grow in lab dishes and in lab animals by injecting cell growth factors or factors that re-activate certain genes that were silenced after embryonic development.

Observations made during such studies suggested that the Muller glia cells could be artificially stimulated to start dividing again, and to show light-detecting receptors.

However, all those studies had failed to detect any regenerated inner retina nerve cells, except when the Muller glia cells were genetically modified with genes that specifically promote the formation of amacrine cells, which act as intermediaries in transmitting nerve signals.

"This was puzzling, because in chicks amacrine cells are the primary retinal cells that are regenerated after injury," Reh said.

With a view to resolving the discrepancy between what was detected in chicks and not detected in rodents, the researchers carried out a systematic analysis of the response to injury in the mouse retina, and the effects of specific growth factor stimulation on the proliferation of Muller glia cells.

They injected a substance into the retina to eliminate ganglion cells, a type of nerve cell found near the surface of the retina, and amacrine cells. Then by injecting the eye with epidermal growth factor (EGF), fibroblast growth factor 1 (FGF1) or a combination of FGF1 and insulin, they were able to stimulate the Muller glia cells to re-start their dividing engines and begin to proliferate across the retina.

The proliferating Muller glia cells first transformed into unspecialised cells, something that the researchers were able to detect by checking for chemical markers that indicate progenitor cells.

Soon some of the general cells changed into amacrine cells, and the researchers detected their presence by checking for chemicals produced only by amacrine cells.

The researchers observed that many of the progenitor cells arising from the dividing Muller glia cells died within the first week after their production, but those that managed to turn into amacrine cells survived for at least 30 days.

"It's not clear why this occurs, but some speculate that nerve cells have to make stable connections with other cells to survive," the researchers wrote.

Source-ANI

Osiris completes enrollment in Phase III GVHD trial

2008-12-07T09:15:00.000-08:00

Dec 05, 2008 (Datamonitor via COMTEX)

Osiris Therapeutics, a stem cell therapeutic company, has completed patient enrollment in its Phase III pivotal trial evaluating Prochymal for the treatment of steroid-refractory acute graft versus host disease.

This double-blinded, placebo controlled trial will assess safety and efficacy of Prochymal over a six-month period. A total of 244 patients were enrolled at 72 leading bone marrow transplant centers across the US, Canada, the UK, Spain, Italy, Australia, Germany and Switzerland.

In total, 168 patients were treated in the US, 31 in Canada, 27 in Europe, and 18 in Australia. A total of 27 pediatric patients were enrolled. The last patient is expected to complete the trial by May 29, 2009.

Prochymal is a proprietary formulation of adult mesenchymal stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.

Osiris and Genzyme have previously announced a strategic alliance for the development and commercialization of Prochymal. Under the terms of the agreement, Osiris will commercialize Prochymal in the US and Canada, and Genzyme will commercialize the treatment in all other countries.

Moya Daniels, study director for the steroid-refractory graft versus host disease (GVHD) program at Osiris, said: "On behalf of everyone at Osiris, I would like to offer our sincere appreciation to the patients, their families, and all of the outstanding healthcare professionals who participated in this historic event. We look forward with great anticipation to the results of this landmark stem cell trial and the opportunity to make a positive difference in the care of transplant patients everywhere."

Reversing Destructive Eye Diseases Maybe Just a Supplement Away

2008-11-22T17:48:00.000-08:00

Dr. Brian Lewy- Dr. Jay Stockman

Americans have pursued a never ending search for nutrients, and supplements in an effort to improve ocular health and prevent eye diseases. While many advertized items have little or no actual benefit, there are some that have been shown to be helpful, and efficacious. Over the last half century research has started to embrace these supplements as beneficial to our health, and their impact on one’s general well being.

Understanding the aging, and physiological processes offers a pathway to the benefits of these nutrients. Cataracts, Macular Degeneration, dry eyes and other age related disorders are but a few of the considerations that these neutricuticals are targeted to address. A study conducted by West and associates concluded that there are some supplements that are very helpful and when taken properly will prevent damage and even do some repair.

Research conducted by the Age Related Eye Disease Study ( AREDS) found that individuals who took antioxidant combinations of 500 IU Vit C, 400 IU Vit E, 15 mg of beta carotene and Zinc for approximately 6 years had a 17%-21% lower rate of Age Related Macular Degeneration(ARMD) progression as compared to individuals in the placebo group. Patients who took Zinc or antioxidants alone also showed a decrease in the progression of ARMD, but not to the extend as the first group. No benefit was shown with the folks who took Vit E alone. In addition, participants who took Lutein for 18-20 weeks demonstrated higher plasma levels, and increased macular pigment density. This would counter the ARMD damage and improve visual quality.
The West and associate study found no benefit at all in preventing, improving or reversing the damage caused by Cataracts or Diabetic Retinopathy. Herbal remedies, antioxidants, and all vitamins were found to be useless with regard to these two conditions.

Unlike cataracts, Glaucoma has been shown to be aided by the use of supplements. Cannabinoids have demonstrated an ability to lower the intraocular pressure, thereby lowering the visual devastations of Glaucoma. The problem with this supplement is obtaining an accepted method of administration that is regulated, dose reproducible and legal. Additional studies have shown that Ginkgo Biloba has improved the visual fields of normal tension glaucoma patients with as little as four weeks of use. The reason is believed to be the vasodilating affect of this supplement. Bringing more blood, and oxygen to the starved retinal tissue. Bilberry has not been clinically demonstrated to aid glaucoma patients in any way.

While additional studies must be conducted to asses all the benefits of these, and other nutritional supplements, it is clear that some do help. Furthermore, of equal importance is the drug interaction of supplements with both each other and prescription medicines. Many herbs, drugs and supplements can and do increase/ decrease the affect of other substances when present at the same time. Care must always be taken and warnings displayed. In all cases, one must consult with their health care professionals as to what supplements can be safely used.

Spotting eye disease sooner

2008-11-22T17:46:00.000-08:00

Roxanne Stein

BACKGROUND: Macular degeneration is the age-related degenerative process of the macula. The macula is the area of the retina that is responsible for fine visual acuity. Macular degeneration can make it difficult or impossible to read and recognize faces and it's a major cause of blindness in the elderly. Age-related macular degeneration (AMD) begins with characteristic yellow deposits in the macula, called drusen. People with drusen can go on to develop advanced AMD. The risk is considerably higher when the drusen are large and numerous and associated with disturbance in the pigmented cell layer under the macula. Recent research suggests that large and soft drusen are related to elevated cholesterol deposits and may respond to cholesterol lowering agents.

There are two forms of AMD -- wet and dry. Central geographic atrophy, the dry form of AMD, results from atrophy to the retinal pigment epithelial layer below the retina, which can lead to blindness through loss of photoreceptors (rods and cones) in the central part of the eye. Neovascular or exudative AMD, the wet form of AMD, causes vision loss due to abnormal blood vessel growth in the choriocapillaries, ultimately leading to blood and protein leakage below the macula. Bleeding, leaking and scarring from these blood vessels can eventually cause irreversible damage to the photoreceptors and rapid vision loss if left untreated.

DIAGNOSING: The traditional way to diagnose macular degeneration has been with the Amsler Grid Test. The Amsler Grid is a pattern of intersecting lines, identical to a piece of graph paper, with a black dot in the center. A person with normal vision can fixate on the dot while still seeing the grid patterns. A person with macular degeneration will see part of the grid missing, or some of the grid lines will appear to be bent or unevenly spaced.

A new test called prospective hyperacuity perimetry, or PHP, is able to detect the change from dry to wet AMD. The computerized test is more accurate because it has a higher sensitivity level. It will detect a change from dry macular degeneration to the wet form faster or at an earlier stage than traditional testing. PHP testing works by showing a series of linear dots in a pattern and it tests the entire 14 degrees of the macular fields. It tests small portions at a time in a prearranged sequence. The patient is asked to detect if any of the dots arranged in a line are out of space. The PHP test also incorporates some dot sequences that really are out of order, allowing it to test a patient's reliability in answering. A computer records the data and can detect even the smallest changes in a patient's macula over time.

Ophthotech Enrolls First Patient in a Phase I Complement (Anti-C5) Inhibitor Trial for Macular Degeneration

2008-11-22T17:41:00.000-08:00

ARC1905 Represents Second Compound in Clinical Development

PRINCETON, NJ and NEW YORK, NY--(Marketwire - October 27, 2008) - Ophthotech Corp. ("Ophthotech"), a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, announced today the enrollment of its first patient in a complement inhibition trial for the treatment of age-related macular degeneration (AMD). This Phase I trial will assess the safety and tolerability of ARC1905, an anti-C5 complement factor aptamer, in combination with an anti-VEGF agent.

Dr. Donald J. D'Amico, Professor and Chairman, Department of Ophthalmology, Weill Cornell Medical College, New York-Presbyterian Hospital, and a member of Ophthotech's Scientific Advisory Board, said, "Multiple lines of evidence now point to a fundamental problem with inflammation and complement activation in patients with high susceptibility to develop AMD. Intervention in the complement pathway is the single most promising target for new therapeutic and preventive strategies for AMD."

"Preclinical and human genetic linkage studies strongly support the significant role of complement-mediated inflammation in both dry and wet AMD," said Samir Patel, M.D., President and Chief Executive Officer of Ophthotech. "We believe that anti-C5 aptamer blockade represents a potential breakthrough therapy for both wet and dry forms of AMD."

Published studies in Science, the New England Journal of Medicine and other leading journals suggest that abnormalities involving the complement pathway may be responsible for the majority of cases of dry and wet forms of AMD in the western world.

ARC1905 represents one of three compounds that Ophthotech is developing to treat AMD. Additional molecular entities include E10030, an anti-PDGF aptamer currently in a Phase I study, and volociximab, an anti-angiogenic monoclonal antibody targeting the alpha5beta1 integrin, which is on track to commence clinical trials in the near future.

About ARC1905
Anti-C5 aptamer ARC1905 inhibits C5, a central component of the complement cascade, which plays multiple roles in innate immunity and inflammatory diseases. Inhibition of this key step in the complement cascade at the level of C5 prevents the formation of key terminal fragments (C5a and C5b-9) regardless of which pathway (alternate, classical or lectin) induced their generation. The C5a fragment is an important inflammatory activator inducing vascular permeability, recruitment and activation of phagocytes. C5b-9 is involved in the formation of membrane attack complex (MAC: C5b-9), which initiates cell lysis. By inhibiting these C5-mediated inflammatory and MAC activities, therapeutic benefit may be achieved in both dry and wet AMD. In August 2007, Ophthotech licensed worldwide rights to all ophthalmic uses of Archemix's proprietary aptamers (ARC186 and ARC1905) targeting the C5 component of the complement cascade.

About E10030
E10030, currently being investigated in a Phase I trial, is an aptamer-based compound directed against PDGF-B. Pharmacology studies indicate that E10030 binds to PDGF-B with high specificity and affinity and inhibits the functions of PDGF-B both in vitro and in vivo. In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF-A inhibitor. In experiments involving models of ocular vascularization, concurrent inhibition of PDGF-B and VEGF-A signaling was superior to inhibition of the VEGF-A pathway alone.

About Volociximab (M200)
Volociximab is a monoclonal antibody targeting alpha5beta1 integrin, a key protein involved in the formation of new blood vessels, a process known as angiogenesis. alpha5beta1 integrin is a critical survival factor for proliferating endothelial cells involved in angiogenesis. Inhibition of alpha5beta1 integrin has demonstrated potent anti-angiogenic effects in multiple pre-clinical models of angiogenesis.

About AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for "wet" AMD. "Dry" AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, "dry" AMD can progress to the wet form of the disease.

About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a Series A venture financing and two separate in-licensing deals with Archemix Corp. and Eyetech, Inc., which recently spun out of (OSI) Eyetech. A third in-license from Biogen Idec and PDL BioPharma was announced in January of 2008. Ophthotech's venture investors include SV Life Sciences, HBM BioVentures and Novo A/S. For more information, please visit www.ophthotech.com.

Using Bifocal Reading Glasses

2008-11-22T17:39:00.000-08:00

Telescopic glasses are among the latest of the numerous low vision aids used to help people in dealing with macular degeneration symptoms. While there is no cure for age related macular degeneration (AMD), there are macular degeneration treatments available that can assist such patients in maximizing what sight they do have; telescopic glasses are possibly among the most effective, both in terms of cost and effectiveness.

In some ways, these remarkable devices – also known as bioptics - are similar to bifocal reading glasses. They essentially work the same way; patients utilize these macular degeneration devices by tilting their heads forward. These particular macular degeneration devices are different however in their construction. Unlike bifocal reading glasses, which integrate two different prescriptions into single lenses, telescopic glasses actually consist of miniature telescopes that sit atop the frames.

The marvelous aspect of telescopic glasses – also known as bioptics - is the fact that they can be adjusted in the same way as many full-sized telescopes. As low vision aids for the relief of macular degeneration symptoms, telescopic glasses can be adjusted for a variety of activities requiring far, mid-range and near vision.

In fact, some states actually allow those who cannot pass the eye test for driving to operate a motor vehicle as long as bioptics are used. While there are usually restrictions, the use of telescopic glasses can help the patient to regain some measure of independence. These low vision aids are of great help in seeing road signs and other objects on the highway.

Telescopic glasses are like regular glasses, and if you plan on driving with them, you’ll need an optometrist’s prescription. Even if you’re not planning to operate an automobile (and admittedly, this is not appropriate for everyone – or even very many – people with macular degeneration symptoms), the use of these remarkable low vision aids can greatly add to your quality of life.

With the use of bioptics, people who use such macular degeneration devices can once again enjoy watching television and motion pictures, engage in artistic pursuits such as sculpture and painting or music requiring reading, and engage in their favorite sports.
Of course, because macular degeneration symptoms affect one’s central vision and because different activities in life require different kinds of vision, there is no one single solution. Bioptics are only one part of a comprehensive solution that will most likely require several different types of macular degeneration devices. Only your optometrist can advise you as to which of these prosthetic devices can be of most good in helping your particular case.

Medical Treatment

2008-11-21T08:48:00.001-08:00

No one has found a treatment of or a cure for the dry form of age-related macular degeneration.

Antioxidants: Deficiencies in antioxidants (specifically zinc and vitamins A, C, and E) have been noted in some people with age-related macular degeneration. Antioxidants may protect against age-related macular degeneration by preventing free radicals or unstable oxygen from damaging the retina.

The wet form of age-related macular degeneration is more likely than the dry form to cause significant vision loss. Different treatments of the wet form are available and may help decrease the amount of vision that is lost.

Laser treatment: Clinical trials have demonstrated the value of laser treatment for some people with the wet form.
- Laser treatment may stop or lessen vision loss in early stages of the disease.
- A laser beam destroys existing blood vessels and may stop the growth of new ones.
- A scar forms after the laser treatment. This produces a permanent loss of vision in that area of the retina, sacrificed in order to preserve the rest of the eye layer.
- Vision usually does not improve after laser treatment. It works in about half the cases, and only a small number of people meet the criteria for laser treatment. Its limitations have prompted a search for other forms of therapy.
Photodynamic therapy: In April 2000, the U.S. Food and Drug Administration (FDA) approved this treatment. A light-activated drug called verteporfin (Visudyne) is given intravenously and uses a laser to close the abnormal vessels while leaving the retina intact. You may need several treatments over one to two years because closed blood vessels can reopen within the treated area. Because Verteporfin is activated by light, exposure to sunlight must be avoided for five days after treatment.
Antioxidants: Deficiencies in antioxidants have been noted in some people with age-related macular degeneration. Antioxidants may protect against age-related macular degeneration by preventing free radicals or unstable oxygen from damaging the retina.
A variety of drugs that block vascular endothelial growth factor (VEGF) are being evaluated as a treatment option.