Research: AGE-RELATED EYE DISEASE STUDY,

Listed in Issue 231

Abstract

AGE-RELATED EYE DISEASE STUDY, (1)Division of Epidemiology and Clinical Research, National Institutes of Health, Bethesda, Maryland; (2)EMMES Corp, Rockville, Maryland; (3)National Eye Institute, Clinical Trials Branch, Bethesda, Maryland; (4)Department of Ophthalmology, University of Wisconsin-Madison; (5)National Eye Institute, Bethesda, Maryland; (6)Elman Retina Group, Baltimore, Maryland; (7)Charlotte Eye Ear Nose and Throat, Charlotte, North Carolina; (8)Associated Retinal Consultants, William Beaumont Hospital, Royal Oak, Michigan; (9)Ingalls Memorial Hospital, Harvey, Illinois; (10)Department of Ophthalmology, Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore, Maryland; (11)Texas Retina Associates, Dallas, Texas; (12)Emory University, Atlanta, Georgia; (13)Department of Ophthalmology, Casey Eye Institute, Oregon Health and Science

University, Portland;(14)Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison School of Medicine and Public Health; (15)Department of phthalmology and Visual Sciences, University of Wisconsin-Madison School of Medicine and Public Health15Fundus Photograph Reading Center, University of Wisconsin-Madison (16)Department of Ophthalmology, University of Pittsburgh School of Medicine,

Pittsburgh, Pennsylvania; (17)Unit on Neuron-Glia Interactions in Retinal Disease, National Eye Institute, National Institutes of Health, Bethesda, Maryland; (18)Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, Florida; (19)Duke University Medical Center, Durham, North Carolina; (20)Department of Ophthalmology and Visual Sciences, Moran Eye Center, University of Utah Health Sciences Center, University of Utah, Salt Lake City further examined the effect of lutein/zeaxanthin supplementation on  progression to late AMD.

Background

The Age-Related Eye Disease Study (AREDS) formulation for the treatment of age-related macular degeneration (AMD) contains vitamin C, vitamin E, beta carotene, and zinc with copper. The Age-Related Eye Disease Study 2 (AREDS2) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina.

Methodology

The Age-Related Eye Disease Study 2 is a multicenter, double-masked randomized trial of 4203 participants, aged 50 to 85 years, at risk for developing late AMD; 66% of patients had bilateral large drusen and 34% had large drusen and late AMD in 1 eye. Interventions: In addition to taking the original or a variation of the AREDS supplement, participants were randomly assigned in a factorial design to 1 of the following 4 groups: placebo; lutein/zeaxanthin, 10 mg/2 mg; omega-3 long-chain polyunsaturated fatty 3 acids, 1.0 g; or the combination. Main Outcomes And Measures: Documented development of late AMD by central, masked grading of annual retinal photographs or by treatment history.

Results

In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratio of the development of late AMD was 0.90 (95% CI, 0.82-0.99; P = .04). Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 (95% CI, 0.69-0.96; P = .02) for development of late AMD, 0.78 (95% CI, 0.64-0.94; P = .01) for development of neovascular AMD, and 0.94 (95% CI, 0.70-1.26; P = .67) for development of central geographic atrophy. In analyses restricted to eyes with bilateral large drusen at baseline, the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.76 (95% CI, 0.61-0.96; P = .02) for progression to late AMD, 0.65 (95% CI, 0.49-0.85; P = .002) for neovascular AMD, and 0.98 (95% CI, 0.69-1.39; P = .91) for central geographic atrophy.

Conclusion

The totality of evidence on beneficial and adverse effects from AREDS2 and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements.

References

Age-Related Eye Disease Study 2 (AREDS2) Research Group, Chew EY(1), Clemons TE(2), Sangiovanni JP(3), Danis RP(4), Ferris FL 3rd(5), Elman MJ(6), Antoszyk AN(7), Ruby AJ(8), Orth D(9), Bressler SB(10), Fish GE(11), Hubbard GB(12), Klein ML(13), Chandra SR(14), Blodi BA(15), Domalpally A(14), Friberg T(16), Wong WT(17), Rosenfeld PJ(18), Agrón E(5), Toth CA(19), Bernstein PS(20), Sperduto RD(2). Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 132(2):142-9. Feb 2014. doi: 10.1001/jamaophthalmol. 7376. 2013. Comment in JAMA Ophthalmol. 132(2):139-41. Feb 2014;  JAMA Ophthalmol.132(7):904. Jul 2014;  JAMA Ophthalmol. 132(7):904-5. Jul 2014.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00345176.

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