Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 55 or more with unilateral exudative AMD
- •Visual acuity less or equal to 20/25 in the most affected eye
排除标准
- •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
结局指标
主要结局
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
时间窗: 24 months
What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye?
次要结局
- Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months(24 months)