New Nationwide Study Will Evaluate Effect of Antioxidants and Fish Oil on Progression of Age-Related Macular Degeneration (AMD)

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Nearly 100 Clinical Centers Are Now Seeking 4,000 Study Participants Ages 50-85 Who Have AMD

10/12/06

The National Institutes of Health (NIH) announces a nationwide study to see if a modified combination of vitamins, minerals, and fish oil can further slow the progression of vision loss from AMD, the leading cause of vision loss in the United States for people over age 60. This new study, called the Age-Related Eye Disease Study 2 (AREDS2), will build upon results from the earlier Age-Related Eye Disease Study (AREDS). The original study results were released five years ago today. The study found that high-dose antioxidant vitamins and minerals (vitamins C and E, beta-carotene, zinc, and copper), taken by mouth, reduced the risk of progression to advanced AMD by 25 percent, and the risk of moderate vision loss by 19 percent.

AREDS2 will refine the findings of the original study by adding lutein and zeaxanthin (plant-derived yellow pigments that accumulate in the macula, the small area responsible for central vision near the center of the retina) and the omega-3 fatty acids DHA and EPA (derived from fish oils) to the study formulation. The main study objective is to determine if these nutrients will decrease a person’s risk of progression to advanced AMD, which often leads to vision loss. Previous observational studies have suggested these nutrients may protect vision.

“Vision loss from AMD is an important public health issue. This study may help us find a better way to treat this devastating disease,” said Elias A. Zerhouni, M.D., director of the NIH.

AMD damages the macula. As the disease progresses, it blurs the patient’s central vision. AMD can take two forms, wet and dry. Wet AMD is caused by the abnormal growth of blood vessels under the macula. This leads to rapid loss of central vision. Wet AMD is considered to be advanced AMD and is more severe than the dry form. Dry AMD, the more common form, occurs when the light-sensitive cells in the macula slowly break down. Untreated dry AMD can progress into wet AMD.

Paul A. Sieving, M.D., Ph.D., director of the National Eye Institute (NEI) at NIH, said, “Nearly two million Americans have vision loss from advanced AMD, and another seven million with AMD are at substantial risk for vision loss. In the AREDS study, we found a combination of vitamins and minerals that effectively slowed the progression of AMD for some people. Now, we will conduct this more precisely-targeted study to see if the new combination of nutrients can reduce AMD progression even further. This study may help people at high risk for advanced AMD maintain useful vision for a longer time.”

Emily Y. Chew, M.D., study chair and deputy director of the Division of Epidemiology and Clinical Research at the NEI said, “The AREDS2 study is seeking 4,000 people between 50 and 85 years of age with AMD in both eyes, or advanced AMD in one eye. They must be available for yearly eye examinations for at least five years. Until we get the results from AREDS2, we encourage people with AMD to visit their eye care professional to see if they need to take the AREDS vitamin and mineral formulation. This alone could save more than 300,000 people from vision loss over the next five years.”

For a list of study centers, eligibility requirements, and other information, go to: http://www.nei.nih.gov/AREDS2, or call 1-877-AREDS-80 (1-877-273-3780).

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