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 Vitreomacular Traction (VMT).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
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 vitreomacular traction.
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 >_ 18 years of age with vitreomacular traction
排除标准
- •PVD present at baseline
- •Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- •Vitreous hemorrhage
- •Patients who have had a vitrectomy in the study eye at any time
研究组 & 干预措施
ocriplasmin 75µg single injection
Ocriplasmin 75µg single injection versus sham injection
干预措施: ocriplasmin (Drug)
ocriplasmin 125µg single injection
Ocriplasmin 125µg single injection versus sham injection
干预措施: ocriplasmin (Drug)
ocriplasmin 175µg single injection
Ocriplasmin 175µg single injection versus sham injection
干预措施: ocriplasmin (Drug)
ocriplasmin 125µg multiple injections
Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.
干预措施: ocriplasmin (Drug)
sham injection
sham injection
干预措施: Sham Comparator (Drug)
结局指标
主要结局
Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
时间窗: Day 14
次要结局
- Resolution of Vitreomacular Traction (Investigator's Assessment)(Day 28)