NCT01487629Unknown2 期
Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Central subfield macular thickness (CSFT) change
研究概览
简要总结
The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
- •Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
- •Central subfield macular thickness greater than 300 µm
排除标准
- •High-risk proliferative diabetic retinopathy
- •Previous treatment for DME in the past three months
研究组 & 干预措施
Bevacizumab
Experimental
Treatment of macular edema with intravitreal Bevacizumab
干预措施: Bevacizumab (Drug)
Ranibizumab
Experimental
Treatment of macular edema with intravitreal Ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Central subfield macular thickness (CSFT) change
时间窗: Monthly from baseline to Week 48
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
次要结局
- Best-corrected visual acuity change(Monthly from baseline to week 48)
研究者
Rodrigo Jorge
Principal investigator
University of Sao Paulo
研究点 (1)
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