Resveratrol for Exudative Age-Related Macular Degeneration

Study Overview
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Brief Summary
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This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

Detailed Description
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Interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration. Comparison of incidence of choroidal neaovascularization between each study group will be performed.

Official Title
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Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.

Conditions
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AMD, Age-related Macular Degeneration, Choroidal Neovascularisation

Intervention / Treatment
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* Dietary Supplement: Resvega
* Dietary Supplement: Trans-Resveratrol
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 55 or more with unilateral exudative AMD Visual acuity less or equal to 20/25 in the most affected eye Exclusion Criteria: Allergy to an investigational product atrophic Age-Related Macular Degeneration or age related maculopathy significant media opacities Other retinal pathology (diabetic retinopathy, high myopia, retinal dystrophy) Recent Cataract surgery Previous history of vitrectomy Acute or chronic severe organ failure Present participation in other clinical research study

Ages Eligible for Study
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Minimum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-Resveratrol<br>capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months | Dietary Supplement: Trans-Resveratrol<br>* Dietary supplementation with resveratrol 250 mg BD<br>|
| Active Comparator: Resvega<br>capsule composed of antioxydant, omega 3, carotenoid, 15 mg of resveratrol, zinc and copper. two capsules daily : one in the morning and evening for 24 months | Dietary Supplement: Resvega<br>* Dietary supplementation with Resvega BD<br>|
| Placebo Comparator: Placebo<br>capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months | Dietary Supplement: placebo<br>* Dietary supplementation with a placebo BD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months | What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye? | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months | What is the influence of the daily intake resvega on the incidence of neovascularization of the second eye? | 24 months |