Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (MADEOS)

This is an interventional treatment trial for Dry AMD focused on measuring Omega-3, dry AMD, Stargardt, visual acuity Read More

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.