Resveratrol for Exudative Age-Related Macular Degeneration (AGED)

Poitiers University Hospital

Status: Terminated

Conditions: Choroidal Neovascularisation; AMD; Age-related Macular Degeneration

Treatments: Dietary Supplement: Resvega; Dietary Supplement: placebo; Dietary Supplement: Trans-Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT02625376

AGED/EudraCT : 2015-001577-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups, including a placebo group

Trans-Resveratrol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Trans-Resveratrol

Resvega

Active Comparator group

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

Treatment:

Dietary Supplement: Resvega

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo