Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
研究概览
简要总结
The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.
详细描述
Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic macular edema with central foveal measurement over 300 micrometers
排除标准
- •Vitreoretinal surgery
- •Cataract Surgery less than 3 months prior inclusion
- •Unilateral cataract surgery
- •Uncontrolled Glycosylated Hemoglobin
- •Previous Intraocular Injection
- •Systemic Corticosteroids less than 1 month prior inclusion
- •Macular ischemia at Fluorescein Angiography
- •Cataract precluding fundus examination
- •Active Proliferative Diabetic Retinopathy
研究组 & 干预措施
bevacizumab
干预措施: Bevacizumab (Drug)
Triamcinolone
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
时间窗: 6 months
次要结局
- To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.(6 months)
- To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.(6 months)