Resveratrol for Exudative Age-Related Macular Degeneration

Not Applicable

Terminated

• Conditions: Choroidal Neovascularisation; Age-related Macular Degeneration; AMD
• Interventions: Dietary Supplement: Resvega; Dietary Supplement: Trans-Resveratrol; Dietary Supplement: placebo

• Registration Number: NCT02625376
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08-06
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Primary Completion: 2016-10-26
• Study Completion: 2016-11-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resvega	Resvega	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
Trans-Resveratrol	Trans-Resveratrol	capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months
Placebo	placebo	capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months

Primary Outcome Measures

Name	Time	Method
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months	24 months	What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye?

Secondary Outcome Measures

Name	Time	Method
Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months	24 months	What is the influence of the daily intake resvega on the incidence of neovascularization of the second eye?

Trial Locations

Locations (1)

CHU de Poitiers - Ophtalmology; 🇫🇷 Poitiers, France