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Resveratrol for Exudative Age-Related Macular Degeneration (AGED)

Primary Purpose

AMD, Age-related Macular Degeneration, Choroidal Neovascularisation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Resvega
Trans-Resveratrol
placebo
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for AMD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Poitiers - Ophtalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Trans-Resveratrol

Resvega

Placebo

Arm Description

capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months

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

capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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?

Full Information

First Posted
August 6, 2015
Last Updated
May 29, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02625376
Brief Title
Resveratrol for Exudative Age-Related Macular Degeneration
Acronym
AGED
Official Title
Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Study Start Date
August 6, 2015 (Actual)
Primary Completion Date
October 26, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AMD, Age-related Macular Degeneration, Choroidal Neovascularisation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trans-Resveratrol
Arm Type
Experimental
Arm Description
capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months
Arm Title
Resvega
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Resvega
Intervention Description
Dietary supplementation with Resvega BD
Intervention Type
Dietary Supplement
Intervention Name(s)
Trans-Resveratrol
Intervention Description
Dietary supplementation with resveratrol 250 mg BD
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Dietary supplementation with a placebo BD
Primary Outcome Measure Information:
Title
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
Description
What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye?
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months
Description
What is the influence of the daily intake resvega on the incidence of neovascularization of the second eye?
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas LEVEZIEL, MD, PhD
Organizational Affiliation
Dpt of Ophthalmology, University Hospital of Poitiers, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Poitiers - Ophtalmology
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

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Resveratrol for Exudative Age-Related Macular Degeneration

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