NCT00913744已完成2 期
A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)
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
- 100
- 试验地点
- 27
- 主要终点
- Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
研究概览
简要总结
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged > 50
- •Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
- •Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- •The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
- •The total lesion area must be < 12 disc areas
- •Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
- •Subjects with visual acuity of 20/32 to 20/200 in the study eye
- •Written informed consent obtained from the subject prior to inclusion in the study
排除标准
- •Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
- •Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
- •Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
- •Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
- •Subjects with high myopia (> 8D) or aphakia in the study eye
- •Subjects who have had ocular surgery in the study eye in the prior three months
- •Subjects who have had a vitrectomy in the study eye at any time.
研究组 & 干预措施
Ocriplasmin
Experimental
干预措施: Ocriplasmin (Drug)
Sham injection
Sham Comparator
干预措施: Sham injection (Drug)
结局指标
主要结局
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
时间窗: Day 28
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
次要结局
未报告次要终点
研究者
研究点 (27)
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