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Resveratrol for Exudative Age-Related Macular Degeneration (AGED)

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ClinicalTrials.gov Identifier: NCT02625376
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 489 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.
Study Start Date : August 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019


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




Primary Outcome Measures :
  1. Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months [ Time Frame: 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 :
  1. Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months [ Time Frame: 24 months ]
    What is the influence of the daily intake resvega on the incidence of neovascularization of the second eye?



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625376


Contacts
Contact: Nicolas LEVEZIEL, MD, PhD +33 (0)5.49.44.41.82 nicolas.leveziel@chu-poitiers.fr

Locations
France
CHU de Poitiers - Ophtalmology Recruiting
Poitiers, France, 86000
Contact: Nicolas leveziel, MD       nicolas.leveziel@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Nicolas LEVEZIEL, MD, PhD Dpt of Ophthalmology, University Hospital of Poitiers, France

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02625376     History of Changes
Other Study ID Numbers: AGED/EudraCT : 2015-001577-41
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Resveratrol
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents