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

Study Overview
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Brief Summary
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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.

Detailed Description
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Age-related macular degeneration (AMD) is the leading cause of blindness in developed countries. By the year 2040, the number of people suffering from AMD is estimated to increase by 50%. Stargardt disease is the most prevalent form of macular dystrophy in children, with an estimated prevalence of 1 in 10000. There is no effective treatment available that stops progression or improves vision in patients with dry AMD or Stargardt disease. Considering the success in animal studies and observational human studies with omega-3 fatty acids supplementation when the blood ratio AA (arachidonic acid)/EPA (eicosapentaenoic acid) is <2, the sponsor hypothesizes that, when the blood ratio of AA/EPA is maintained below 2, the visual acuity in the group with active supplements will improve, in comparison to the control group, in patients with moderate and severe dry AMD and moderate and severe Stargardt.

Official Title
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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

Conditions
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Dry AMD, Stargardt Disease 1

Intervention / Treatment
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* Dietary Supplement: Madeos
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 fatty acids<br>Omega 3 fatty acids | Dietary Supplement: Madeos<br>* Arm 1: Omega 3<br>|
| Placebo Comparator: Placebo<br>Placebo (sunflower oil) | Dietary Supplement: Placebo<br>* Arm 2 : Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of letters (BCVA) from screening to 24 weeks | Mean change of letters (BCVA) from screening to 24 weeks | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3, dry AMD, Stargardt, visual acuity