NCT00664183终止2 期
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects
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
- 400
- 试验地点
- 4
- 主要终点
- Ultrasound
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
- 30 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 PVD at baseline exam in the study eye.
排除标准
- •Subjects with Retinal pathology in the study eye other than (NPDR)
- •Subjects with high myopia in the study eye
- •Subjects who have monocular vision or contra 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 than 6 months prior to study enrollment
- •Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.
研究组 & 干预措施
1
Experimental
干预措施: Vitreosolve (Drug)
2
Experimental
干预措施: Vitreosolve (Drug)
结局指标
主要结局
Ultrasound
时间窗: 7 Months
次要结局
- Ultrasound, OCT, Safety(7 Months)
研究者
研究点 (4)
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