Resveratrol for Exudative Age-Related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

— AGED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02625376
• Other study ID #: AGED/EudraCT : 2015-001577-41
• Status: Terminated
• Phase: N/A
• Start date: August 6, 2015
• Est. completion date: November 9, 2016

Study information

• Verified date: May 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 9, 2016
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• AMD
• Choroidal Neovascularisation
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Dietary Supplement:
• Resvega
Dietary supplementation with Resvega BD
• Trans-Resveratrol
Dietary supplementation with resveratrol 250 mg BD
• placebo
Dietary supplementation with a placebo BD

Locations

Country	Name	City	State
France	CHU de Poitiers - Ophtalmology	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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?	24 months