Abstract
Purpose :
The need for an effective therapeutic intervention in patients with vision loss due to retinal degeneration still remains high. We performed a multicentre, prospective, randomised, double-blind, placebo-controlled study to investigate the effects of omega-3 fatty acids in patients with dry age-related macular degeneration (AMD) or Stargardt disease (SD).
Methods :
The main inclusion criterion was the best-corrected visual acuity (BCVA) to be between 21 and 55 (ETDRS letters) at screening visit. The final number of patients was 21; of those, 9 females and 12 males, with mean age 60.0 ± 2.3 years. Treatment consisted of daily oral administration of either placebo (sunflower oil; 7 patients) or active product (Eyetas®, 3.7g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); EPA:DHA=5:1; 14 patients), for 24 weeks. The number of letters gained from BCVA measurements and the ratio of arachidonic acid (AA)/EPA (using gas chromatography) was determined at screening, 12 weeks and 24 weeks. The total score of a questionnaire on perceived vision and subjective mood was obtained at 12 weeks and 24 weeks. The SPSS software (version 25.0) was used for the statistical analyses.
Results :
Within the active group, the mean BCVA increased from 40.93 ± 9.18 at screening to 46.93 ± 9.18 at 24 weeks (p=0.003; Wilcoxon signed-rank test), whereas within the placebo group there was no significant increase. A comparison of the mean letters gained at 24 weeks showed a significant difference between the active and placebo groups (p=0.002; independent samples t-test). Similar findings were obtained for the letters gained at 12 weeks.
For the active group, the mean level of AA/EPA had a significant decrease from screening (5.84 ± 1.05) to 12 weeks (1.50 ± 0.23, p=0.002, Wilcoxon signed ranks tests) and 24 weeks (1.47 ± 0.16, p=0.002), whereas for the placebo group, the AA/EPA had no significant differences. Finally, the mean score of the questionnaire was similar in the two groups at 12 weeks (9.23 ± 3.14 in active, 9.33 ± 2.42 in placebo), but it was higher for the active group compared to the placebo group at 24 weeks (9.38 ± 3.35 vs. 7.28 ± 2.36).
Conclusions :
Oral supplementation of omega-3 fatty acids (3.7g; EPA:DHA=5:1) can improve objective and subjective vision in patients with dry AMD and SD.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.