AREDS

Age-Related Eye Disease Study

The AREDS Study is a randomized, placebo-controlled clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration. This trial included 11 centers.

Abstracted From Archives of Ophthalmology 2001;119:1417-1436

DEFINITIONS Randomized = A scientific method is used to select those who are put on treatment. Two groups are necessary so that a statistically significant difference can be detected between those who were given treatment versus those who were given no treatment or placebo. Placebo = A pill, supplement, or intervention which simulates the treatment but does not contain the materials studied. A typical pill-shaped placebo is ''a sugar pill." High-Dose = More than the recommended daily requirement.

Patient Characteristics: The 4754 Patients (55-80 years old) that were enrolled had either extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, pigment abnormalities in 1 or both eyes, advanced AMD, or vision loss due to AMD in 1 eye. At least 1 eye had best-corrected visual acuity of 20/32 or better.

Treatment: Participants were randomly assigned to receive daily oral tablets containing: (1) antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg); (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide; (3) antioxidants plus zinc; or (4) placebo.

Results:
Participants with extensive small drusen, nonextensive intermediate size drusen, or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD. Odds reduction estimates increased when these 1063 participants were excluded. Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in the higher-risk groups. The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc (OR, 0.73; 99% CI, 0.54-0.99). No statistically significant serious adverse effect was associated with any of the formulations.

Conclusion: Persons older than 55 years should have dilated eye examinations to determine their risk of developing advanced AMD. Those with extensive intermediate sized drusen, at least 1 large druse, noncentral geographic atrophy in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye (without contraindications such as smoking) should consider taking a supplement of antioxidants plus zinc as used in this study.

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