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NEI seeks clinical, academic sites for AREDS 2
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CHICAGO — With the NEI’s Age-Related Eye Disease Study now complete, a proposed AREDS 2 is scheduled to begin in 2006, announced Emily Y. Chew, MD, one of the researchers in the original trial.
Dr. Chew said the NEI anticipates the participation of 40 to 60 clinical and academic sites in the study, and the institute is accepting applications from study sites until November 23. She spoke about the proposed trial at the American Academy of Ophthalmology meeting here.
Observational data suggest that lutein and omega-3 fatty acids may reduce risk for AMD, Dr. Chew said, and the AREDS 2 will test that hypothesis clinically.
The objective of the study will be to evaluate treatment outcomes using lutein, zeaxanthin and omega-3 fatty acids, as well as a combination of the treatments.
The design of the AREDS 2 will be similar to the original AREDS, with 25% of patients taking placebo, 25% taking a supplement containing lutein and zeaxanthin, 25% taking a supplement containing omega-3 fatty acids and 25% taking a combination of the two.
“We will look at moderate vision loss and progression to AMD as well as cataract surgery and progression along the AREDS AMD scale,” Dr. Chew said in a press release issued during the American Academy of Ophthalmology meeting.
The population will involve at-risk patients as well as patients with advanced AMD.
“AMD accounts for a very wide part of our patients with vision loss, and that is more than 50%,” Dr. Chew said. “We’ve already seen that the combination of antioxidants and zinc reduces the risk of vision loss and progression to AMD. … We’re hoping this will give us further protection from AMD if possible.”
The application for study sites can be downloaded from www.areds2.org.