A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 20
- 主要终点
- Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
研究概览
简要总结
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom vitrectomy is indicated
排除标准
- •Posterior Vitreous Detachment (PVD) present at baseline
- •Vitreous hemorrhage
- •Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- •Have had a vitrectomy in the study eye at any time
研究组 & 干预措施
Ocriplasmin 25µg
25µg of ocriplasmin intravitreal injection
干预措施: Ocriplasmin 25µg (Drug)
Ocriplasmin 75µg
75µg of ocriplasmin intravitreal injection
干预措施: Ocriplasmin 75µg (Drug)
Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
干预措施: Ocriplasmin 125µg (Drug)
Placebo
Intravitreal injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
时间窗: Day 7
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
次要结局
未报告次要终点