Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Star… (NCT03297515) | Clinical Trial Compass
CompletedNot Applicable
Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease
France, Germany, Italy32 participantsStarted 2019-05-15
Plain-language summary
Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women ages from 18 to 85 years old.
* Group 1: For moderate dry macular degeneration the BCVA must be between 50 and 70 (ETDRS) at Screening Visit V1. There must be a large drusen \>125 µm within 1mm from the centre of the fovea. Geographic atrophy can be present but must be \>300 µm away from centre of fovea;
* Group 2: For severe dry macular degeneration the BCVA must be between 41 and 49 (ETDRS) at Screening Visit V1. Geographic atrophy can involve the fovea but must be \<2500 µm in diameter or any size GA but \>200 µm from centre of fovea anywhere;
* Group 3: For moderate Stargardt disease the BCVA must be between 50 and 70 (ETDRS) at Screening Visit V1. The geographic area must be \<2.0 mm in diameter anywhere;
* Group 4: For severe Stargardt disease the BCVA must be between 41 and 49 (ETDRS) at Screening Visit V1. The geographic area must be \<2.5 mm in diameter anywhere;
* Willingness to take the randomised trial investigational product for 6 months;
* Willingness to consent and undergo the examinations/blood testing at the visits;
* Be able to swallow large soft gel capsules;
* Take other supplements as usual; The EPA and DHA intake must be less than 1200 mg/day.
Exclusion Criteria:
* Any ocular disease in either eye including: Diabetic retinopathy, Central serous retinopathy, Epiretinal membrane, Optic atrophy, Macular hole or pseudohole, Retinal vein occlusion, Amblyopia;
* Previous wet AMD in the study eye;
* Any previous ocular sur…
What they're measuring
1
Mean change of letters (BCVA) from screening to 24 weeks
Timeframe: 24 weeks
Trial details
NCT IDNCT03297515
SponsorOphthalmos Research and Education Institute