Resveratrol for Exudative Age-Related Macular Degeneration

NCT ID: NCT02625376

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-06

Study Completion Date

2016-11-09

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.

Conditions

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AMD Age-related Macular Degeneration Choroidal Neovascularisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Trans-Resveratrol

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

Group Type EXPERIMENTAL

Trans-Resveratrol

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation with resveratrol 250 mg BD

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

Group Type ACTIVE_COMPARATOR

Resvega

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation with Resvega BD

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation with a placebo BD

Interventions

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Resvega

Dietary supplementation with Resvega BD

Intervention Type DIETARY_SUPPLEMENT

Trans-Resveratrol

Dietary supplementation with resveratrol 250 mg BD

Intervention Type DIETARY_SUPPLEMENT

placebo

Dietary supplementation with a placebo BD

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas LEVEZIEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt of Ophthalmology, University Hospital of Poitiers, France

Locations

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CHU de Poitiers - Ophtalmology

Poitiers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37702300 (View on PubMed)

Other Identifiers

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AGED/EudraCT : 2015-001577-41

Identifier Type: -

Identifier Source: org_study_id

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