NCT00412451已完成2 期
A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.
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
- 51
- 试验地点
- 15
- 主要终点
- PVD Induction
研究概览
简要总结
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
Ocriplasmin 25µg
Experimental
25µg ocriplasmin intravitreal injection versus sham injection
干预措施: ocriplasmin (Drug)
Ocriplasmin 75µg
Experimental
75µg ocriplasmin intravitreal injection versus sham injection
干预措施: ocriplasmin (Drug)
Ocriplasmin 125µg
Experimental
125µg ocriplasmin intravitreal injection versus sham injection
干预措施: ocriplasmin (Drug)
sham injection
Sham Comparator
Sham injection
干预措施: Sham injection (Other)
结局指标
主要结局
PVD Induction
时间窗: Day 14 post-injection
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
次要结局
未报告次要终点
研究者
研究点 (15)
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