Stargardt Disease 1 Clinical Trial
— MADEOSOfficial title:
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
NCT number | NCT03297515 |
Other study ID # | TG2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2019 |
Est. completion date | September 22, 2020 |
Verified date | February 2021 |
Source | Ophthalmos Research and Education Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 22, 2020 |
Est. primary completion date | September 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 surgery, which may influence progression of dry macular degeneration e.g. trabeculectomy, previous refractive surgery, pterygium surgery. Cataract surgery more than 6 months is not an exclusion criterion unless a complication has occurred during surgery; - Any topical medication administered for other diseases such as glaucoma. Artificial tears up to 3/day will be allowed; - Any ocular condition such as allergic conjunctivitis, moderate to severe dry eyes, scleritis, uveitis, keratitis, ocular Herpes Simplex keratitis, ectropion, entropion, ocular surface scaring; - Any systemic conditions such as gastrointestinal disease e.g. irritable bowel syndrome, Crohn's disease, cancer, etc; - Any drugs which could affect the eye administered up to 6 months before screening e.g.: Steroids, Ethambutol, Tamoxifen, Chloroquine, Hydroxychloroquine; - Any condition that would not allow follow up e.g. alcoholism or drug abuse; - Allergy to any ingredients of the active or placebo pills. - Pregnant or lactating; - Current use of EPA/DHA supplements in excess of 1200 mg/day; - History of liver disease; - Anti-coagulation therapy such as warfarin/heparin/aspirin/dabigatran/ clopidogrel etc; - Bleeding tendencies e.g. coagulopathies; - History of atrial fibrillation; - Inability to give informed consent (impaired mental capacity e.g. psychiatric deficit); - Smokers or patients who have not been completely smoke free over the past 5 years. |
Country | Name | City | State |
---|---|---|---|
France | Centre National d'Ophtalmologie des Quinze-Vingts | Paris | |
Germany | Department of Ophthalmology, Justus-Liebig-University-Giessen | Gießen | |
Italy | Università degli Studi G. d'Annunzio Chieti-Pescara | Chieti | |
Italy | ASST Santi Paolo e Carlo | Milan | |
Italy | Department of Ophthalmology, University Vita Salute | Milan |
Lead Sponsor | Collaborator |
---|---|
Ophthalmos Research and Education Institute |
France, Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change of letters (BCVA) from screening to 24 weeks | Mean change of letters (BCVA) from screening to 24 weeks | 24 weeks |
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