A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
研究概览
简要总结
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
- •Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
- •BCVA of 20/800 or better in the non-study eye;
- •Provide written informed consent;
- •Follow specified instructions during study period;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
- •Vitreous hemorrhage or other opacification;
- •High myopia in the study eye;
- •Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
- •Uncontrolled glaucoma in the study eye;
- •History of retinal detachment in either eye;
- •Active infection in either eye;
- •Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
- •Participation in another investigational drug study within 30 days prior to this study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Ocriplasmin
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
干预措施: Ocriplasmin (Drug)
Sham injection
Single sham injection to the study eye at baseline
干预措施: Sham injection (Drug)
结局指标
主要结局
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
时间窗: Day 28
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.
次要结局
未报告次要终点