First Author: A.Piatti ITALY
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Several epidemiological data provided the rationale for using antioxidants or other nutrients in the treatment of Age-related Macular Degeneration (AMD). The aim of this study was to evaluate the effect of a long-term supplementation of a specific product containing a mixture of carotenoids, antioxidants and Omega-3 fatty acids on AMD progression.
This study was performed by Ophthalmologists of the GOAL group (study nickname: GOAL in AMD). GOAL is a Scientific Association of italian ophthalmologists operating in Primary Care Commmunity. The study adhered to the tenets of the Declaration of Helsinki for research involving human subjects and was approved by Ethics Committee.
This was a multicentre, prospective, double blind, placebo-controlled trial. Eighty patients with intermediate AMD (Category 3 by AREDS classification) were randomized (2:1 ratio) to receive a 1 tablet/day of a commercially available nutritional supplement based on carotenoids, vitamins and Omega-3 fatty acids (Azyr Mega SIFI; Catania, Italy) or placebo, for 2 years. The primary outcome of the study was the evaluation of AMD progression/stabilization assessed by digital fundus photography. Other measures included Best Corrected Visual Acuity (BCVA) assessed by both ETDRS and MNRead charts. The eye with the BCVA was selected, when both eyes had the same BCVA, the right eye was selected for the final analysis These variables were evaluated independently or in combination by using the Chi-square test or the Fisher Exact Test.
Seventy-four patients completed the follow up at 24 months. After 2 years, 47/48 patients (97.9%) in the treatment arm had a stabilization of digital fundus photography, whereas this occurred only in 21/26 patients (80.8%) in the placebo arm. This difference was statistically significant (p=0.0183, Fisher Exact test). The Odd Ratio for treatment group was 11.1 (95%CI=1.2-101.3). Differences between groups observed for BCVA (ETDRS and MNRead) were not statistically significant. When all three parameters were evaluated in combination, 48/48 patients in the treatment arm were stabilized ; by contrast this occurred only to 23/26 ( 88.5%) of patients in the placebo arm. This difference was statistically significant (p=0.040, Fisher Exact test).
This study suggests that a clinically meaningful stabilization of Intermediate AMD ( category 3 by AREDS) may be obtained by treating patients with a commercially available mixture of carotenoids, vitamins and Omega-3 fatty acids. Further studies including more patients and longer follow up are needed to confirm such results.