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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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