AGED: Resveratrol for Exudative Age-Related Macular Degeneration

Sponsor

Poitiers University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02625376

Collaborator

(none)

Enrollment

Location

Arms

15.1

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
AMD Age-related Macular Degeneration Choroidal Neovascularisation	Dietary Supplement: Resvega Dietary Supplement: Trans-Resveratrol Dietary Supplement: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 6, 2015

Actual Primary Completion Date :

Oct 26, 2016

Actual Study Completion Date :

Nov 9, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Poitiers - Ophtalmology	Poitiers		France	86000

Sponsors and Collaborators

Poitiers University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT02625376

Other Study ID Numbers:

AGED/EudraCT : 2015-001577-41

First Posted:

Dec 9, 2015

Last Update Posted:

Jun 1, 2020

Last Verified:

May 1, 2020

Additional relevant MeSH terms:

Macular Degeneration

Choroidal Neovascularization

Neovascularization, Pathologic

Resveratrol

Study Results

No Results Posted as of Jun 1, 2020