Carotenoids With Coantioxidants vs. Placebo in Early AMD
Irish investigators reported the secondary outcomes in the Carotenoids with Coantioxidants in Age-Related Maculopathy trial.
Participants in this randomized, double-masked, placebo-controlled clinical trial included 433 adults 55 years of age or older with early age-related macular degeneration (AMD) in one eye and late-stage disease in the fellow eye (group one) or early AMD in both eyes (group two). Intervention consisted of an oral preparation containing lutein (L), zeaxanthin (Z), vitamin C, vitamin E, copper and zinc or placebo. The investigators performed best-corrected visual acuity (BCVA), contrast sensitivity (CS), Raman spectroscopy, stereoscopic color fundus photography and serum sampling every six months with a minimum follow-up time of 12 months. 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).
According to the study investigators, 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.
To conclude, the investigators observed functional and morphologic benefits in key secondary outcomes after supplementation with L, Z and coantioxidants in persons with early AMD.