NCT01823965已完成2 期
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of intravitreal injections of ranibizumab
研究概览
简要总结
In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus (1 or2)
- •decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity<69 letters using E.T.D.R.S testing)
- •macular edema
排除标准
- •history of severe cardiac disease
- •stroke within 12 months
- •intraocular inflammation
研究组 & 干预措施
ranibizumab
Experimental
干预措施: ranibizumab (Drug)
结局指标
主要结局
Number of intravitreal injections of ranibizumab
时间窗: 1 years
次要结局
- best-corrected visual acuity(1 years)
研究者
研究点 (1)
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