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Secondary Outcomes in a Clinical Trial of Carotenoids with Coantioxidants versus Placebo in Early Age-related Macular Degeneration

Published:December 07, 2012DOI:https://doi.org/10.1016/j.ophtha.2012.08.040

      Purpose

      To report the secondary outcomes in the Carotenoids with Coantioxidants in Age-Related Maculopathy trial.

      Design

      Randomized double-masked placebo-controlled clinical trial (registered as ISRCTN 94557601).

      Participants

      Participants included 433 adults 55 years of age or older with early age-related macular degeneration (AMD) in 1 eye and late-stage disease in the fellow eye (group 1) or early AMD in both eyes (group 2).

      Intervention

      An oral preparation containing lutein (L), zeaxanthin (Z), vitamin C, vitamin E, copper, and zinc or placebo. Best-corrected visual acuity (BCVA), contrast sensitivity (CS), Raman spectroscopy, stereoscopic colour fundus photography, and serum sampling were performed every 6 months with a minimum follow-up time of 12 months.

      Main Outcome Measures

      Secondary outcomes included differences in BCVA (at 24 and 36 months), CS, Raman counts, serum antioxidant levels, and progression along the AMD severity scale (at 12, 24, and 36 months).

      Results

      The differential between active and placebo groups increased steadily, with average BCVA in the former being approximately 4.8 letters better than the latter for those who had 36 months of follow-up, and this difference was statistically significant (P = 0.04). In the longitudinal analysis, for a 1-log-unit increase in serum L, visual acuity was better by 1.4 letters (95% confidence interval, 0.3–2.5; P = 0.01), and a slower progression along a morphologic severity scale (P = 0.014) was observed.

      Conclusions

      Functional and morphologic benefits were observed in key secondary outcomes after supplementation with L, Z, and coantioxidants in persons with early AMD.

      Financial Disclosure(s)

      The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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      Linked Article

      • Visual Outcome After Antioxidant Supplementation
        OphthalmologyVol. 120Issue 3
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          In 2001, the National Eye Institute–funded Age-related Eye Disease Study (AREDS) published its findings.1 The AREDS was a double-masked, randomized, placebo-controlled trial of 4757 subjects over a period of 5 years that showed that supplementation with antioxidants vitamins C and E, β-carotene, and zinc in combination resulted in a 25% relative reduction in the risk of progression from intermediate to advanced and visually consequential age-related macular degeneration (AMD). The AREDS supplement did not contain the macular pigment carotenoids lutein and zeaxanthin, compounds believed to confer protection against development and/or progression of AMD because of their antioxidant and/or optical (blue light-filtering) properties.
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