Do Omega-3 Fatty Acids Help Prevent AMD? (Transcript)

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Lutein + Zeaxanthin and Omega-3 Fatty Acids for Age-Related Macular Degeneration: the Age-Related Eye Disease Study 2 (AREDS2) Randomized Clinical Trial

The Age-Related Eye Disease Study 2 (AREDS2) Research Group
JAMA. 2013;309:2005-2015

The Age-Related Eye Disease Study 2

The Age-Related Eye Disease Study (AREDS) 1 formulation (vitamins C and E, beta carotene, zinc, and copper) has been shown to reduce the risk of developing advanced age-related macular degeneration (AMD) by 25% at 5 years in patients at high risk for progression (patients with advanced AMD in 1 eye, intermediate AMD in 1 or both eyes, 1 or more large drusen [≥ 125 µm] in at least 1 eye or nonsubfoveal geographic atrophy in 1 eye).

In this 5-year multicenter, randomized, double-masked, placebo-controlled phase 3 study in 4203 patients aged 50-85 years, the risk for progression to advanced AMD was assessed in patients taking oral supplementation regimens with lutein (10 mg) + zeaxanthin (2 mg), DHA (350 mg) + EPA (650 mg), and lutein + zeaxanthin with DHA + EPA.

Patients were randomly assigned to 1 of the 4 following treatment groups in an approximately 1:1:1:1 ratio:

Placebo;
Lutein + zeaxanthin;
DHA + EPA; or
Lutein + zeaxanthin with DHA + EPA.

Each group (including the placebo group) also received oral supplementation with the AREDS1 formulation. An optional secondary randomization, evaluating the effects of eliminating beta carotene and/or lowering the zinc dose (from 80 mg to 25 mg) in the AREDS1 formula, was performed in 3036 consenting participants. Follow-up visits were scheduled annually, with follow-up telephone calls at 3 months from randomization and at 6-month intervals between visits. Blood was drawn from 545 participants at years 1, 3, and 5 to measure levels of lipids, lutein + zeaxanthin, fat-soluble vitamins, zinc, and copper.

The primary outcome was the development of advanced AMD, and secondary outcomes were progression to moderate vision loss (≥ 3 lines) from baseline or treatment for choroidal neovascularization. Advanced AMD was defined as central geographic atrophy or retinal features of choroidal neovascularization. Exploratory and post hoc endpoints of the effect of dietary lutein + zeaxanthin and the AREDS1 formulation without beta carotene vs the original AREDS formulation were also examined.

Cite this: Vaidehi S. Dedania, Sophie J. Bakri. Do Omega-3 Fatty Acids Help Prevent AMD? - Medscape - Jan 16, 2014.

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