Resveratrol for Exudative Age-Related Macular Degeneration
AGED
Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedStudy Start
First participant enrolled
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2016
CompletedJune 1, 2020
May 1, 2020
1.2 years
August 6, 2015
May 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months
24 months
Study Arms (3)
Trans-Resveratrol
EXPERIMENTALcapsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months
Resvega
ACTIVE COMPARATORcapsule 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
Placebo
PLACEBO COMPARATORcapsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months
Interventions
Dietary supplementation with resveratrol 250 mg BD
Eligibility Criteria
You may qualify if:
- Men or women aged 55 or more with unilateral exudative AMD
- Visual acuity less or equal to 20/25 in the most affected eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Poitiers - Ophtalmology
Poitiers, 86000, France
Related Publications (1)
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PMID: 37702300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas LEVEZIEL, MD, PhD
Dpt of Ophthalmology, University Hospital of Poitiers, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
December 9, 2015
Study Start
August 6, 2015
Primary Completion
October 26, 2016
Study Completion
November 9, 2016
Last Updated
June 1, 2020
Record last verified: 2020-05