Resveratrol for Exudative Age-Related Macular Degeneration (AGED)

May 29, 2020 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • CHU de Poitiers - Ophtalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trans-Resveratrol
capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months
Dietary supplement: Trans-Resveratrol
Dietary supplementation with resveratrol 250 mg BD
Active Comparator: 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
Dietary supplement: Resvega
Dietary supplementation with Resvega BD
Placebo Comparator: Placebo
capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months
Dietary supplement: placebo
Dietary supplementation with a placebo BD

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Nicolas LEVEZIEL, MD, PhD, Dpt of Ophthalmology, University Hospital of Poitiers, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2015

Primary Completion (Actual)

October 26, 2016

Study Completion (Actual)

November 9, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGED/EudraCT : 2015-001577-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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