Resveratrol for Exudative Age-Related Macular Degeneration (AGED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02625376|
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment|
|AMD Age-related Macular Degeneration Choroidal Neovascularisation||Dietary Supplement: Resvega Dietary Supplement: Trans-Resveratrol Dietary Supplement: placebo|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
U.S. FDA Resources
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
- 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?
- 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?
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
|Contact: Nicolas LEVEZIEL, MD, PhD||+33 (0)email@example.com|
|CHU de Poitiers - Ophtalmology||Recruiting|
|Poitiers, France, 86000|
|Contact: Nicolas leveziel, MD firstname.lastname@example.org|
|Principal Investigator:||Nicolas LEVEZIEL, MD, PhD||Dpt of Ophthalmology, University Hospital of Poitiers, France|