A prospective, multicentre, randomised, double-blind study designed to assess the potential effects of omega-3 fatty acids supplementation in dry age-related macular degeneration or Stargardt disease

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A prospective, multicentre, randomised, double-blind study designed to assess the potential effects of omega-3 fatty acids supplementation in dry age-related macular degeneration or Stargardt disease

Katerina ProkopiouPanagiotis KolovosHaritini Tsangari;  Francesco BandelloLuca M RossettiLeonardo MastropasquaSaddek Mohand-SaidTassos Georgiou

Author Affiliations & Notes

    Katerina Prokopiou
    Ophthalmos Research and Educational Institute, Cyprus
    Basic and Clinical Sciences, University of Nicosia Medical School, Nicosia, Cyprus

    Panagiotis Kolovos
    Ophthalmos Research and Educational Institute, Cyprus

    Haritini Tsangari
    University of Nicosia School of Business, Nicosia, Cyprus

    Francesco Bandello
    Department of Ophthalmology, University Vita Salute scientific Institute of San Raffael Via Olgettina, Milan, Italy

    Luca M Rossetti
    Centre for Clinical Trials at San Paolo Hospital, University of Milan, Milan, Italy

    Leonardo Mastropasqua
    Excellence Eye Research Centre, University G. d’Annunzio of Chieti-Pesara, Ospedale Clinicizzato Via dei Vestini, Italy

    Saddek Mohand-Said
    Centre d’Investigation Clinique Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris, France

    Tassos Georgiou
    Ophthalmos Research and Educational Institute, Cyprus

    Commercial Relationships  Katerina Prokopiou None; Panagiotis Kolovos None; Haritini Tsangari None; Francesco Bandello None; Luca Rossetti None; Leonardo Mastropasqua None; Saddek Mohand-Said None; Tassos Georgiou Ophthalmos Research and Educational Institute, Code P (Patent)

    Investigative Ophthalmology & Visual Science June 2022, Vol.63, 377 – F0208. doi:

    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.

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