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THE NATIONAL ALLIANCE FOR EYE AND VISION RESEARCHE-ZINE Volume 3, Number 1 (January 2007) Welcome to the first edition in 2007 of the National Alliance for Eye and Vision Research's (NAEVR) E-Zine, a quarterly electronic publication that highlights breakthrough eye and vision research funded by the National Eye Institute (NEI). The nation's investment in the NEI results in new treatments and therapies to not only stabilize vision loss but to restore it, or ultimately prevent the onset of eye disease. Vision impairment and eye disease currently cost the United States $68 billion annually in healthcare expenditures, reduced productivity, and diminished quality of life. In this edition:
NAEVR Hosts January 31 Welcome Reception for the 110th Congress Featured Speaker: Wednesday, January 31, 2007 NEI AND FDA HOLD OPEN DISCUSSION ON OPHTHALMIC CLINICAL TRIAL DESIGN AND ENDPOINTS The National Eye Institute (NEI) and the Food and Drug Administration (FDA) held an open meeting on November 28-29, 2006, in Washington, DC, where representatives from both agencies and scientists from various academic centers discussed outcome variables and clinical trial strategies for evaluating new treatments for age-related macular degeneration (AMD) and other diseases of the retina that affect millions of Americans. The format was a roundtable discussion, moderated by Karl G. Csaky, M.D., Ph.D., senior investigator at the NEI. The lead participant from the FDA was Wiley Chambers, M.D. Presenters and discussants addressed issues before 250 audience members from around the world, representing from industry, federal agencies, academia, and vision advocacy groups. In essence, the discussions concerned whether certain clinical findings represent clinically significant changes in visual function and, if so, how this affects the design of clinical trials. The meeting was divided into five sections, with speakers and discussants assigned to each: visual acuity parameters as outcomes measures, endpoints in diabetic retinopathy, design and endpoints for neovascular AMD, design and endpoints for geographic atrophy, and post marketing drug surveillance. CAPT RESULTS DISAPPOINT DOCTORS AND EARLY AMD PATIENTS The NEI-supported CAPT study of more than a thousand people with early signs of AMD has yielded disappointing news for ophthalmologists and patients. CAPT stands for Complications of Age-Related Macular Degeneration Prevention Trial. The hope was that loss of vision or progression of AMD could be slowed by using a low intensity laser treatment to break up deposits under the retina called drusen. Drusen are the first sign of early AMD. The study was designed to test the effectiveness of the laser treatment. No differences were found between treated and untreated eyes. But other research may prove more promising, including the newly launched AREDS2 (see below). NEI LAUNCHES AREDS2 IN HOPES OF FURTHER SLOWING ADVANCE OF AMD People with AMD received good news in 2001 from the large NEI study called the Age-Related Eye Disease Study, or AREDS. It proved that vitamins containing high levels of the antioxidant vitamins C, vitamin E, and beta-carotene, plus zinc and copper, significantly reduce the risk of advanced AMD and its associated vision loss. Now, NEI is looking to build on the AREDS results by adding other nutrients (lutein and zeaxanthin and the omega-3 fatty acids DHA and EPA) to the study formula. AREDS2 will enroll 4000 patients for five years in nearly 100 study centers nationwide. Nearly two million Americans already have vision loss from AMD and millions more with AMD are at risk. This study could have an enormous impact on quality of life for a great many aging Americans. ANOTHER BOOST TO EXERCISE: PROTECTION AGAINST ADVANCED AMD The long-running Beaver Dam Eye Study, founded in 1987 and funded by NEI, recently issued another report based on cumulative evidence from studies of more than 4000 men and women. This one details how people with an active lifestyle (defined as regular activity three or more times each week) are less likely than those who are sedentary to develop the advanced form of AMD. In advanced AMD, blood vessels of the eye leak blood and fluid. Exercise has been shown to improve cardiovascular health. The benefits to the eye may be linked. NEI FUNDS SEARCH FOR NEW WAYS TO DELIVER MEDICINES TO THE INNER EYE Several new drugs (e.g., anti-VEGF compounds) show promise like never before for limiting the extent of vision loss from advanced AMD. But the way they are delivered into the eye is not optimal-by injection, as often as necessary. The NEI recently awarded a 5-year $7 million grant to researchers from Emory University, University of Nebraska, University of Pennsylvania, and Georgia Institute of Technology to work collaboratively to develop new methods for delivering drugs to the inside, back of the eye. Some ideas for delivering the drugs are to use nanoparticles, microneedles, collagen gels, or iontophoresis. BREAKTHROUGH IN TREATMENT FOR COMMON EYE CANCER IN CHILDREN Retinoblastoma, a tumor of the retina, affects about 5,000 very young children worldwide each year. Treatment to shrink the cancer includes aggressive systemic chemotherapy, radiation, laser therapy, and, very often, removal of one or both eyes. A recent discovery reported by NIH-funded researchers from St. Jude's Children's Research Hospital in Memphis, TN, provides hope for shrinking the tumors using a much less expensive and destructive approach. So far its success has only been demonstrated only in mice but the researchers believe the treatment has the potential to make therapy for retinoblastomas far simpler and less toxic. The treatment blocks a molecule that prevents the body from getting rid of abnormal cells that can become cancerous. It may also be tested against breast and colon cancers. NEW IMAGING TECHNOLOGIES WOW OPHTHALMOLOGISTS New computerized optical scanning devices are providing eye researchers and clinicians with high definition views of the inside of the eye like never before. As evaluation of the retina in both health and disease is being revealed, the best way to use the new technologies for diagnosing eye disease and assessing treatments is under debate. The new technology is called optical coherence tomography, or OCT. A big question is how previously undetectable pathologic features of the eye relate to visual function. CELLS TRANSPLANTED TO RETINA SURVIVE IN MICE An NEI-funded international research team has discovered a way to replace degenerating portions of the diseased retina with new, functioning cells, at least in mice. What makes this important? In humans, in many blinding retinal diseases, the light-sensing cells of the eye called photoreceptors die yet their underlying connections for conveying messages to the brain remain. The researchers showed that implanted photoreceptor cells taken at just the right time from donor mice can successfully form connections and improve vision. These findings define the right stage of donor cell development for successful photoreceptor transplantation. The breakthrough could lead to treatments for restoring vision in people with a variety of retinal diseases. NEI CHIEF LEADS NATIONAL NANOMEDICINE DEVELOPMENT CENTERS In the final quarter of 2006 the NIH completed the selection of centers to be part of the Nanomedicine Development Centers (NDCs). The nanomedicine initiative is a component of NIH's Roadmap for Medical Research and is being led by Paul A. Sieving, M.D., Ph.D., director of the National Eye Institute (NEI). The NIH's Roadmap for Medical Research lays out a vision for shortening the time between discoveries in the lab and treatments in the patient. NDC includes biologists, physicians, chemists, physicists, mathematicians, engineers, and computer scientists from eight centers: Georgia Institute of Technology, Purdue University, UCLA, Lawrence Berkeley National Laboratory, Baylor College of Medicine, University of Illinois at Urbana-Champaign, University of California at San Francisco, and Columbia University. They will be using an engineering approach to understand molecular controls of cell structure and function. From this, new strategies will emerge for diagnosing, treating, and preventing disease.
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