Randomized Multicenter Clinical Trial of Three Parallel Groups to Estimate the Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Best-Corrected Visual Acuity (BCVA)
研究概览
简要总结
This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab
干预措施: Bevacizumab (Drug)
Grid laser
It's a reference standard as the treatment which is currently accepted for NTDDME
干预措施: Grid laser (Other)
Triamcinolone 4 mg
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Best-Corrected Visual Acuity (BCVA)
时间窗: 12 months
To evaluate the effect on best-corrected visual acuity (BCVA) of intravitreal triamcinolone (Triesence ®) or bevacizumab (Avastin ®) in combination with grid laser therapy compared to grid laser therapy alone after 12 months of treatment, in diabetic patients with not tractional diffuse macular edema (NTDDEM)
次要结局
- To assess the safety of intravitreal Triesence (r)(Baseline, 3m, 6m and 12 months)
- To measure average change in mean central macular thickness in each group.(Baseline and 3, 6 and 12 months after the treatment was initiated.)
- To assess the safety of intravitreal Avastin (r)(Baseline, 3m, 6m and 12 months)
- To assess the safety of intravitreal grid photocoagulation(Baseline, 3m, 6m and 12 months)