NCT00348439终止2 期
A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Presence of a Grade A Posterior Vitreous Detachment (PVD)
研究概览
简要总结
Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.
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 who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.
排除标准
- •Presence of a posterior vitreous detachment in the study eye
- •History of vitrectomy in the study eye
- •Proliferative diabetic retinopathy in the study eye
- •Presence of media opacity that precludes quality examination of the vitreous and fundus.
研究组 & 干预措施
Plasmin Injection
Experimental
human-derived plasmin
干预措施: Plasmin (Drug)
Vehicle
Placebo Comparator
Plasmin formulation, without active ingredient.
干预措施: Vehicle (Drug)
结局指标
主要结局
Presence of a Grade A Posterior Vitreous Detachment (PVD)
时间窗: 14 Days
PVD at the disc and macula post plamin injection
次要结局
未报告次要终点
研究者
研究点 (1)
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