A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 24
- 主要终点
- Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
研究概览
简要总结
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
详细描述
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.
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
- Quadruple (Participant, Care Provider, 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
- •Subjects 18 years of age or older and of either gender
- •Presence of vitreomacular adhesion
- •Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
- •BCVA of 20/800 or better in the non-study eye
排除标准
- •History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye
- •Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
- •Macular hole of > 400 µm diameter in the study eye
- •Presence of epiretinal membrane (ERM)
- •Aphakia in the study eye
- •High myopia (more than 8D) in study eye
- •History of rhegmatogenous retinal detachment in either eye
- •History of vitrectomy in the study eye
- •Previous participation in this trial or prior administration of ocriplasmin in the study eye
研究组 & 干预措施
Ocriplasmin
干预措施: Ocriplasmin (Drug)
Sham injection
干预措施: Sham injection (Other)
结局指标
主要结局
Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
时间窗: Day 28
Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.
次要结局
- Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24(Month 24)