June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
The Results of the 10 Year Follow-on Study of the Age-Related Eye Disease Study 2 (AREDS2)
Author Affiliations & Notes
  • Emily Y Chew
    National Eye Institute, Bethesda, Maryland, United States
  • Traci E Clemons
    The Emmes Company LLC, Rockville, Maryland, United States
  • Tiarnan D L Keenan
    National Eye Institute, Bethesda, Maryland, United States
  • Elvira Agron
    National Eye Institute, Bethesda, Maryland, United States
  • Claire E Malley
    National Eye Institute, Bethesda, Maryland, United States
  • Amitha Domalpally
    University of Wisconsin-Madison, Madison, Wisconsin, United States
  • Footnotes
    Commercial Relationships   Emily Chew, None; Traci Clemons, None; Tiarnan Keenan, None; Elvira Agron, None; Claire Malley, None; Amitha Domalpally, None
  • Footnotes
    Support  EY000546; AREDS2 Contract HHS-N-260-2005-00007-C; ADB contract NO1-EY-5-0007; AREDS Contract NOI-EY-0-2127
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 1215. doi:
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    • Get Citation

      Emily Y Chew, Traci E Clemons, Tiarnan D L Keenan, Elvira Agron, Claire E Malley, Amitha Domalpally; The Results of the 10 Year Follow-on Study of the Age-Related Eye Disease Study 2 (AREDS2). Invest. Ophthalmol. Vis. Sci. 2021;62(8):1215.

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      © ARVO (1962-2015); The Authors (2016-present)

  • Supplements

Purpose : To assess the long-term effects of adding lutein/zeaxanthin and omega-3 fatty acids to the Age-Related Eye Disease Study (AREDS) supplements on age-related macular degeneration (AMD) progression and adverse side-effects.

Methods : The AREDS2 clinical trial randomly assigned participants with bilateral intermediate AMD or late AMD in one eye to lutein/zeaxanthin and/or omega-3 fatty acids or placebo. Secondary randomization also evaluated varying doses of beta-carotene (0 vs. 15 mg) and zinc (25 vs. 80 mg). At the end of the clinical trial, a follow-up study was conducted with 6-monthly telephone calls to the surviving AREDS2 participants from the central coordinating center to collect outcome data and adverse events for safety monitoring for an additional 5 years. Medical records were obtained from treating physicians to validate any self-reported diagnosis or treatment of late AMD and cataract and side-effects. AREDS2 supplements with lutein/zeaxanthin, vitamin C and E, and zinc plus copper were provided to all participants during this additional follow-up. Repeated measures logistic regression was used in the primary analyses.

Results : 6360 study eyes (3887 participants) were analyzed and 3047 (48%) progressed to late AMD. The main effects of lutein/zeaxanthin vs. no lutein-zeaxanthin and of omega-3 fatty acids vs. no omega-3 fatty acids resulted in hazard ratios of 0.91 (95% CI: 0.89-0.99) (p=0.03) and 1.00 (0.92-1.09) (p=0.91), respectively. When the lutein/zeaxanthin main effect analysis was restricted to those randomized secondarily to beta-carotene, the HR was 0.80 (0.69-92) (p=0.003). On direct analysis of lutein/zeaxanthin vs. beta-carotene, the HR was 0.85 (0.74-0.98) (p=0.026). For the comparisons of low vs. high zinc and no beta-carotene vs. beta-carotene, the HRs were 1.04 (p=0.48) and 1.04 (p=0.50), respectively. For those randomized to beta-carotene, the odds ratio (OR) of developing lung cancer was 1.92 (1.11-3.31)(p=0.02) while the OR for those randomized to lutein/zeaxanthin was 1.19 (0.82-1.73) (p=0.35).:

Conclusions : The 10-year Follow-on study replicated the findings of the randomized clinical trial at 5 years. Lutein/zeaxanthin, when compared with beta-carotene, had an incremental beneficial effect on progression to late AMD. Beta-carotene doubled the risk of lung cancer, providing support for lutein/zeaxanthin as a replacement of beta-carotene in the AREDS2 supplements

This is a 2021 ARVO Annual Meeting abstract.


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