AREDS II to test refined AREDS formulation

Chicago-The Age-Related Eye Disease Study II (AREDS II) will begin soon after the AREDS ends in December 2005. The study aims to refine the findings of AREDS, which demonstrated that oral supplementation with high-dose antioxidant vitamin and minerals (vitamins C and E, beta-carotene, zinc, and copper) reduced the risk of advanced age-related macular degeneration (AMD) by 25%. Emily Chew, MD, deputy director of the Division of Epidemiology and Clinical Research, National Eye Institute, National Institutes of Health, Bethesda, MD, explained the study design of AREDS II Friday during the retina subspecialty day at the American Academy of Ophthalmology meeting.

“AREDS is an important study because, while this supplementation is not a cure, reducing vision loss is a very important issue,” Dr. Chew said. “If all 8 million people at high risk of AMD were to take the AREDS supplement, we could save 300,000 patients from vision loss over the next 5 years.”

AREDS II aims to improve on this by revisiting the xanthophylls (lutein and zeaxanthin) and omega 3 (docosahexaenoic acid and eicosapentaenoic acid). Patients with categories 3 and 4 AMD will receive placebo (n = 1,000), lutein and zeaxanthin (n = 1,000), omega 3 (n = 1,000), or all three (n = 1,000), according to Dr. Chew, who explained that these nutrients are of particular interest because of the mounting evidence of their beneficial effect in AMD. The primary study objective is to determine whether these nutrients decrease the risk of progression to advanced AMD compared with placebo.

In addition, AREDS II will refine the AREDS formulation by including a second randomization in patients assigned to the AREDS formulation. Specifically, 1,000 patients will not receive AREDS supplements and 3,000 patients will receive one of the following: the AREDS supplements, the supplement with no beta-carotene (found to be detrimental in patients who smoke), the supplement with a low dose of zinc (15 mg) (reduced from 80 mg because of adverse events in AREDS patients), or the supplement with no beta-carotene and a low dose of zinc.

“The new design of AREDS II will maximize our opportunity to answer important questions in the treatment of AMD,” Dr. Chew said.