NCT00908778Unknown3 期
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Ultrasound, OCT, and clinical exam
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects with a history of systemic diabetes(type I,or II)
- •Subject with a documented history of Non- proliferative Diabetic Retinopathy(NPDR)
- •Subjects with no or partial PVD at baseline exam in study eye.
排除标准
- •Subjects with retinal pathology in the study eye other then (NPDR)
- •Subjects with high myopia in the study eye
- •Subjects who have monocular vision or central lateral vision of 20/200 or worse BCVA in the non-study eye.
- •Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less then 6 months prior to study enrollment.
- •Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.
研究组 & 干预措施
Vitreosolve I
Experimental
Intravitreal injection
干预措施: Vitreosolve (Drug)
Vitreosolve
Experimental
Intravitreal injection
干预措施: Vitreosolve (Drug)
结局指标
主要结局
Ultrasound, OCT, and clinical exam
时间窗: 6 months
次要结局
- Ultrasound ,OCT ,Safety, and Clinical Exam(6 months)
研究者
研究点 (5)
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