Secondary outcomes in a clinical trial of carotenoids with coantioxidants versus placebo in early age-related macular degeneration

Ophthalmology. 2013 Mar;120(3):600-606. doi: 10.1016/j.ophtha.2012.08.040. Epub 2012 Dec 6.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Antioxidants / therapeutic use*
  • Ascorbic Acid / blood
  • Ascorbic Acid / therapeutic use
  • Contrast Sensitivity / physiology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluorometry
  • Humans
  • Lutein / blood
  • Lutein / therapeutic use*
  • Macular Degeneration / blood
  • Macular Degeneration / drug therapy*
  • Macular Degeneration / physiopathology
  • Male
  • Mass Spectrometry
  • Middle Aged
  • Spectrum Analysis, Raman
  • Tablets
  • Trace Elements / therapeutic use
  • Treatment Outcome
  • Visual Acuity / physiology
  • Vitamin E / blood
  • Vitamin E / therapeutic use
  • Xanthophylls / blood
  • Xanthophylls / therapeutic use*
  • Zeaxanthins


  • Antioxidants
  • Tablets
  • Trace Elements
  • Xanthophylls
  • Zeaxanthins
  • Vitamin E
  • Ascorbic Acid
  • Lutein

Associated data

  • ISRCTN/ISRCTN94557601