Age-Related Macular Degeneration (AMD) / AREDS Trial
Age-Related Eye Disease Study (AREDS)
In this study, 3,640 participants aged 55 to 80 received either antioxidants, zinc or a combination of antioxidants and zinc or placebo with or without the addition of a multivitamin/mineral supplement (at RDA-level doses). The combination study product contained 500 mg of vitamin C, 400 IU of vitamin E, and 15 mg of beta carotene, or zinc (80 mg of zinc as zinc oxide and 2 mg of copper as cupric oxide to prevent potential anemia). Participants with varying stages of AMD took two tablets twice per day and were evaluated every 6 months beginning 2 years after randomization through the 5-year follow-up period by stereoscopic color fundus photographs of the macula.
This study found that there was a reduction in the risk of progressing to more advanced stages of AMD (Stage 4 in both eyes) and central vision loss. A total of 635 participants with Stage 3 (intermediate) or Stage 4 (advanced dry form in one eye only) AMD received the combination of antioxidant plus zinc (zinc alone 21/11 antiox 17/10). Those with no AMD (Stage 1) aged 60 and older had a very low risk of developing AMD over a 7-year period (the duration of the AREDS study) and less than a one percent chance of vision loss from AMD. In those with Stage 2 early AMD, neither of the study products slowed the progression to Stage 3 Intermediate AMD. Persons older than 55 should have dilated eye examinations and consider taking an AREDS formula supplement with high levels of antioxidants and zinc.
Age-Related Eye Disease Study 2 (AREDS2®)
AREDS2 is a multi-center randomized trial of approximately 4,200 participants designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) for the treatment of AMD and cataract. AREDS2 was designed to evaluate the effects of high supplemental doses of lutein and zeaxanthin and omega-3 LCPUFAs on the development of advanced AMD. The study enrolled participants aged 50 to 85, with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs. Subjects were enrolled on the basis of the AREDS Simplified Severity Scale for defining risk categories for development of advanced age-related macular degeneration. All participants are offered additional treatment with the original AREDS formulation (now considered standard of care1) and 3 variations of this formula. These are: (1) no beta-carotene; (2) lower amounts of zinc; and (3) no beta-carotene and lower amounts of zinc. Eligible participants are followed for a minimum of five years.
For more information from the National Eye Institute on the Age-Related Eye Disease Study and AREDS2, click here.
AREDS2 is a registered trademark of the United States Department of Health and Human Services (HHS). AREDS2® is an ongoing study that is expected to end in 2013.
- https://web.emmes.com/study/areds2/resources/areds2_protocol.pdf accessed on 8-25-2011.