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April 2008 Newsletter

Low Vision In The Public Limelight

On Monday March 17, 2008 David Paterson made history by becoming the first legally blind governor of New York. This has thrust low vision into public consciousness like few times in past.

The media is filled with questions about how well a partially sighted person can function in a job as demanding as governor of the Empire State. This has presented those of us in the low vision community with a historic opportunity to enlighten the public about the capabilities of blind and partially sighted individuals. With Governor Patterson as a poster child of the high-achieving blind person, we can make significant progress in overcoming bias against hiring persons with vision loss for demanding, personally satisfying, higher paying jobs.

There is reason to be hopeful. The statistic that is frequently bantered about is 70% of blind persons are unemployed. But that figure is misleading. It includes many elderly, retired persons that have no desire to return to work. Once a person with low vision gets some career training, and is psychologically ready to reenter the workforce, his chances of finding a job have never been better.

In today's workforce, there are more jobs that require computer skills than require good vision. It has never been easier for the vision impaired to find gainful employment. The New York Times quotes Barry Honig, the blind president of Honig International, a Manhattan-based executive search and management consulting firm as saying "With technology today, there is no excuse [for persons with low vision] to not be able to get a job." Yes, we still have a lot of work to do to level the playing field. But having David Paterson in a position of national prominence will help make that job a lot easier.

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Avastin Versus PDT/triamcinolone: 6-month Follow-up Results

A new study finds that Avastin therapy for neovascular age-related macular degeneration (AMD) has significantly better visual outcomes than the combination therapy of photodynamic therapy (PDT) plus intravitreal triamcinolone. Patients receiving Avastin gained a mean of more than two lines compared with a stable visual outcome in patients treated with PDT/triamcinolone. Both treatments were equally effective in causing regression of the neovascular membrane and return of normal macular thickness as measured by fluorescein angiography and optical coherence tomography (OCT).

Twenty-eight patients with neovascular AMD were enrolled in a prospective, randomized, controlled clinical trial. All patients were randomly assigned to receive either Avastin or PDT. In the Avastin-treated group mean visual acuity (VA) improved 2.2 lines at 6 months follow-up. Eyes treated in the PDT/triamcinolone group had no change in VA at month 6 compared with baseline. There was no significant difference in the reduction of macular thickness on OCT testing between the two treatment groups. The mean number of treatments was 4.5 out of seven possible treatments in the Avastin-treated group and 1.9 out of three possible treatments in the PDT-treated group. No significant adverse effects were observed in either group.

The authors conclude that Avastin therapy produces significantly better visual outcomes than PDT/triamcinolone therapy. It is still a mystery why vision did not improve with PDT/trimacinolone therapy, despite the fact that it is just as effective in reducing retinal thickness as Avastin. The authors speculate that a modified PDT/triamcinolone treatment protocol might improve visual outcomes.

WHAT IT MEANS TO YOU: This study demonstrates that Avastin provides superior visual acuity outcomes compared to PDT/triamcinolone. However, the better vision comes at a cost: an average of 4.5 injections compared to just 2 PDT/triamcinolone treatments over 6 months. Evidence is accumulating that with OCT monitoring it is possible to safely decrease the number of required anti-VEGF injections, but the retreatment burden of anti-VEGF therapy is still much higher than with PDT/triamcimolone. It is hoped that a modification of the PDT/triamcinolone treatment protocol can be found that will improve it's visual acuity outcomes. Until then, anti-VEGF therapy remains the treatment of choice for neovascular AMD.

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Fundus Autofluorescence Enhances Our Understanding Of Macular Disease

Fundus autofluorescence (FAF) is a new imaging technology that enables the visualization of lipofuscin densities within the retina. Clinicians and research scientists are able to use this information to better understand and manage a variety of retinal diseases, including age-related macular degeneration (AMD).

Lipofuscin is a waste product that accumulates within the retina as a result of the normal aging process. The material will fluoresce (glow) when excited by ultraviolet or blue light. In this way, it is possible to visualize and measure the amount of lipofuscin in the eye noninvasively. It is believed that accumulation of lipofuscin in the retina is of critical importance in the development and progression of AMD.

Excessive lipofuscin appears to compromise essential RPE functions and contributes to the development of a variety of eye diseases, including AMD and Stargardt's macular dystrophy. High levels of lipofuscin is associated with inflammation, complement system activation, and oxidative damage.

FAF imaging is being employed in both the research laboratory and the clinic. An important clinical application of FAF imaging is to map metabolic changes within the retina of patients with AMD. Because alterations found on FAF do not always correspond to lesions seen using conventional tools such as ophthalmoscopy or angiography, FAF represents a new and unique window into disease activity.

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Evolving Anti-VEGF Treatment Protocols For AMD

Although wet AMD only comprises 10% of all cases of AMD, it is responsible for 90% of vision loss due to AMD. Anti-VEGF therapy is now the standard first-line therapy for wet AMD. However, because of issues associated with cost and dosing frequency, research is currently focused on strategies to optimize treatment delivery.

Despite the excellent outcomes of injecting ranibizumab (Lucentis) monthly as seen in the MARINA and ANCHOR trials, such a schedule is not generally desirable, because it is time-consuming, costly, and increases the risk of side effects from injection. The question of the necessity of monthly injections has been investigated in the PIER and PrONTO studies.

The PIER study sought to address the dosing frequency issue by treating patients with 3 monthly doses followed by quarterly injections for the next 21 months. The results were mixed. Treated patients experienced better outcomes than control patients, but the results were not as impressive as those seen from the monthly dosing of the MARINA and ANCHOR trials.

With that in mind, the PrONTO study was designed to reduce treatment frequency by establishing 5 criteria that include fluorescein angiography and OCT for re-treatment with Lucentis. Outcomes in the PrONTO study were similar to those in the MARINA and ANCHOR trials, with about 35% of patients gaining at least 15 letters. However, the amount of testing performed in PrONTO may not be practical in a busy clinic, and modified criteria are often used by practicing clinicians.

The "treat and extend" method, for instance, has been developed to rely on biomicroscopy and OCT findings to determine the need for re-treatment. In this approach, for every visit in which patients do not show exudative changes, their follow-up injection is extended by an additional 2 weeks. If changes are seen, patients are asked to shorten the next visit interval by 2 weeks. However, treatments are never more frequent than 4 weeks.

So far, the different published studies have not clearly established an anti-VEGF treatment standard, and most ophthalmologists use clinical data to come up with their own treatment guidelines. Approximately 90% of ophthalmologists use OCT alone or combined with FA and/or visual acuity as follow-up testing after anti-VEGF treatment to determine re-treatment.

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Positive Results From Avastin/PDT Combination Therapy Study

Investigators report that results from the Visudyne and Avastin (VIA) clinical trial in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), showed that a combination therapy of verteporfin-photodynamic therapy followed by bevacizumab (Avastin) reduced, by half, the number of treatments required during the first six months to gain similar visual acuity compared to Avastin monotherapy.

Dr. Michael Potter, chief investigator of the VIA clinical trial, which was supported by QLT, the manufacturer of Visudyne, presented results at the 31st Annual Macula Society Meeting on March 28, 2008. The objective of the VIA study was to determine whether Visudyne, at low or very low fluence rates, in combination with Avastin, reduces the average number of treatments required, compared to Avastin alone.

In this 6-month, randomized, controlled, double-masked clinical trial, 36 subjects were assigned to one of three treatment groups: bevacizumab + low fluence (300 mW/cm2) verteporfin PDT; bevacizumab + very low fluence (150 mW/cm2) verteporfin PDT; or bevacizumab + sham PDT. Retreatment decisions were based primarily on OCT.

The average number of bevacizumab treatments in the bevacizumab only group was 5.1, compared to 2.8 in the low fluence and 2.4 in the very low fluence groups. Over 6 months, patients in either of the Avasin plus PDT groups required significantly fewer treatments on average than those treated with Avastin alone. Each group experienced an average improvement in VA at month 6, compared to baseline.

"We are very pleased with the clinical outcomes of this study. Our goal was to see if it is possible to minimize the number of treatments while maintaining or improving visual acuity in patients with CNV secondary to AMD. At six months, virtually all the patients treated with the Visudyne combination therapy gained visual acuity with half the number of treatments required with Avastin monotherapy" said Dr Potter, Associate Professor at Vancouver Hospital University in British Columbia.

WHAT IT MEANS TO YOU: This study finds that Avastin combined with verteporfin PDT using low or very low laser intensity (fluence) can result in disease stabilization and visual acuity improvement comparable to Avastin alone with half the number of required treatments over 6 months. One notable finding from this study was that 30% of subjects in the combination therapy groups required only a single combination treatment whereas all of the Avastin-only subjects required multiple treatments. In our search for ways to decrease the number of required anti-VEGF treatments without sacrificing visual outcome, low fluence verteporfin PDT appears very promising.

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Twenty Year Old Retinal Implant Project Now In Homestretch

The Boston Retinal Implant Project is one of 22 programs around the world working to restore vision lost to degenerative retinal disease, such as age-related macular degeneration and retinitis pigmentosa. Their work: a bio-electronic implant that delivers images to the brain via a connector the width of a human hair.

"There has been this explosion of interest in this field because basically the technology in the last 20 years has become miniaturized enough and sophisticated enough so that for the first time we can imagine building something small enough to put in the eye," said Dr. Joseph Rizzo III, who founded the project in the late 1980s and co-directs the 36-member team.

More than 20 years along, the retinal project is entering its homestretch. An FDA grant application is in the works, they expect to implant it in an animal this summer, and the team's first human surgeries will take place in the next few years.

In its simplest terms, the device, which is implanted behind the retina at the back of the eyeball, works as a light transmitter.

Rizzo said the implant will not restore perfect vision, but will provide patients with a sense of their surroundings - to detect shapes and obstacles in their pathways. Ideally, Rizzo and his team say, patients will someday be able to recognize objects, faces and general detail.

He hopes the prosthesis will one day restore a patient's ability to recognize faces and expressions. But for now, he said, restoring a patient's confidence and ability to move about is a major step.

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Robo4 Protein Inhibits Angiogenesis

Researchers have identified a cell surface protein, dubbed Roundabout (Robo)-4, that appears to be a natural inhibitor of new blood vessel formation.

Other Robo family members play a role in neuronal growth and guidance, but Robo4 is different, said senior study author Dr. Dean Li, of the University of Utah, "mostly in that it was not expressed in nerves but in blood vessels."

Li has spent five years trying to understand the biology of Robo4. "We have been trying to figure out, why is this protein on blood vessels, and that is what this article answers -- what does this thing do?" he explained. The authors found that, when Robo4 was activated, pro-angiogenic activities where blocked.

"What we are saying is the cells of the blood vessels have a protein receptor, and this is called Robo4, and if you activate the Robo4 receptor, by giving it a protein that binds to it, the blood vessel cells know the cells shouldn't leak and grow," Li said.

In mouse models of age-related macular degeneration (AMD) and diabetic retinopathy, activation of Robo4 was able to block abnormal growth of blood vessels and stop existing vessels from leaking, according to Dr Li.

The finding holds promise for new treatments for the two eye diseases, as well as a range of other illnesses caused by excessive formation of blood vessels or leaky vasculature, they said

Several drugs targeting the VEGF-signaling pathway have already been approved by the U.S. Food and Drug Administration, including Avastin, Lucentis and Macugen. Li said the Robo4 biological pathway presents an alternative therapeutic target.

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100% Of Centenarians Develop AMD

A recent study of 150 Brazilians confirmed that patients older than 100 years develop age-related macular degeneration 100% of the time, Dr Marcela Cypel reported at the Curso Regional Panamericano meeting in March 2008.

Cypel presented data on patients more than 80 years old, showing the increasing occurrence of AMD in patients as they reach 80, 90 and 100 years of age.

"I think I can say that if we live [long] enough, we're going to have AMD," Dr. Cypel said.

The study of 150 patients ranging in age from 80 years to 108 years showed 31% of the 70 patients aged 80 to 89 had AMD; 66% of the 50 patients aged 90 to 99 had AMD; and 100% of the 30 patients older than 100 had AMD. Most of these patients were diagnosed with dry AMD, Dr. Cypel said.

She suggested that physicians should continue to educate their patients on dietary supplements, regular ophthalmic visits and the benefits of the Amsler grid for early detection of AMD, especially in light of the prediction that more than 18% of Brazil's population will be older than 80 years by 2050.

WHAT IT MEANS TO YOU: Like so many other age-related conditions, including cataract, it's not a question of whether you will develop AMD, but when. Some people develop it early, others late. It's safe to assume, the earlier you start showing signs of the disease the greater the odds that you will suffer more severe vision loss. So eating right, protecting your eyes from sunlight, and not smoking will help delay its onset, but may not make you immune from AMD if you live to be 110.

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Saffron Protects Retinal Cells From Light-induced Damage

Age-related macular degeneration is a multifactorial disease, with both genetic and environmental factors contributing to its onset. One apparent cause is exposure to harmful radiation in sunlight, especially high-energy blue light. Exposure to intense light can cause photoreceptor death. Several compounds have been found experimentally to protect retinal cells from light-induced damage. Extracts of the spice saffron is one such protective agent.

Saffron is a spice derived from the flower of the saffron crocus. The stigmas of the flower are dried and used in cooking as a seasoning and coloring agent. Saffron has for decades been the world's most expensive spice by weight.

Saffron is used in Chinese medicine as an analgesic and sedative. Studies have demonstrated saffron's ability to prevent tumor formation, atherosclerosis, and liver damage. Saffron has also been shown to have anti-inflammatory effects. Many of the medicinal properties of saffron have been attributed to crocin, a carotinoid, which is also responsible for saffron's golden yellow-orange color, and which makes up approximately 10% of saffron's dry weight.

In the March 2008 edition of the journal Investigative Ophthalmology and Vision Science, researchers report on a study investigating the effect of saffron on the retinal cells of albino laboratory rats. One group of rats were fed a diet rich in saffron, a second group was fed beta-carotene (another carotenoid), and a third group received a normal diet. All of the rats were then subjected to 24 hours of intense bright light. The retinas were then examined for damage. The investigators found that the retinas from the saffron-treated animals were much healthier than the retinas from either the beta-carotene-fed or control animals.

The researchers concluded that that saffron may protect photoreceptors from retinal stress, and probably acts as a regulator of cell death.

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West Va Bill Would Let Those With Low Vision Drive

House Bill 4139 which passed out of the West Virginia Senate Committee on Transportation and Infrastructure on March 4, authorizes a program that would enable people with low vision, to drive with the aid of specially designed bioptic lenses. Individuals would have to complete a training course and pass tests to ensure that they know how to use the devices, said Charles Huss, a private consultant on bioptic driving who testified before the committee early Tuesday. The training program would be housed in Institute, W.Va., and be conducted by the West Virginia Rehabilitation Center, he said. Sen. John Unger, D-Berkeley, who chairs that group, said he supports the bill and others like it that aim to give more autonmy to state residents. "It can be utterly life changing," Huss said, adding if the legislation is approved, West Virginia will join 39 other states that already have bioptic lens programs in place. Delegate Jonathan Miller, R-Berkeley, who introduced a bioptic lens bill during the 2007 legislative session, said he is optimistic that the measure will pass this year.

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Blindness Warning Urged On Cigarettes

Simon Kelly, whose ground-breaking research linked smoking to vision loss, recently addressed experts from across Europe at the International Symposium on Smoking Cessation in Belgium about the links between smoking and age-related macular degeneration, the commonest cause of blindness in Europe. Mr Kelly said: "Currently, cigarette smoking is the major risk factor for the commonest cause of blindness in Europe. The public are largely unaware of this... We are seeking to convince the European Commission of the public health importance of the hazards of smoking on the eyes and for warnings along those lines to now appear on cigarette packets."

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Ontario Second Province To Make Lucentis Available

On March 13 the Ontario Ministry of Health and Long-Term Care announced that patients with wet age-related macular degeneration (AMD) would be eligible for insured treatment with Lucentis (ranibizumab) through the Ontario Public Drug Program. This makes Ontario only the second province, after Quebec, where this innovative treatment is insured. Previously, Ontario patients paid nearly $2,000 per injection which limited the access to this medication and potentially put their vision at risk. The provincial government has earmarked $100 million over three years for Lucentis treatment. The typical cost Lucentis is $2,000 per injection with a general expectation of seven to eight injections in the first year. The government believes that 10,000 patients yearly will require treatment, suggesting that provincial funding for Lucentis severely deficient.

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AMD In Developing Countries

Cataract is still the major cause of blindness in developing nations, but as global populations rapidly age, we are seeing growing numbers of people with age-related eye disease, such as macular degeneration (AMD). The graying of the population is occurring faster in the developing world compared to industrialized nations. It was found that from 1990 to 2002, the number of people over the age of 50 increased by 16% in developed countries, compared to an increase of 47% in developing countries. The state-of-the-art treatment of AMD involves the frequent use of very expensive medications. This brings us to the most critical issue in the management of AMD in developing nations. Treatments can be made widely available only if modern therapeutic agents are made affordable. Government health policy, economic development, and support from nongovernmental organizations can all help to address the growing problem of blindness from AMD. Low vision care with magnifiers can significantly enhance the quality of life for those that have suffered vision loss. These relatively low cost services can be made more widely available in developing countries if sufficient numbers of trained personnel can be found.

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Survey Shows Americans Lack Critical Facts About Maintaining Eye Health

Most Americans do not know the risks and warning signs of diseases that could blind them if they don't seek timely detection and treatment, according to recent findings of the Survey of Public Knowledge, Attitudes, and Practices Related to Eye Health and Disease, sponsored by the National Eye Institute and the Lions Clubs International Foundation. Seventy-one percent of respondents reported that a loss of their eyesight would rate as a 10 on a scale of 1 to 10, meaning that it would have the greatest impact on their day-to-day life. Fifty-one percent said that they have heard that people with diabetes are at increased risk of developing eye disease, but only 11 percent knew that there are usually no early warning signs. Only 16 percent had ever heard the term "low vision," which affects millions of Americans. Hispanic respondents reported the lowest access to eye health information, knew the least about eye health, and were the least likely to have their eyes examined among all racial/ethnic groups participating in the survey.

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MyVisionTest News Feed

RSS news feeds are a great way to stay up-to-date on the news and web sites that interest you. You can subscribe to feeds using a news reader, such as Google Reader. The news feed contains the headlines of all the news items that are available to read, and if you see an item of interest you can then visit the site to read the full story. There is now a MyVisionTest RSS news feed that you can subscribe to. The address of the news feed is http://www.myvisiontest.com/rss.xml

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