NCT00596297已完成1 期
Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intra- and postoperative intra-ocular bleeding
研究概览
简要总结
The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.
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
- None
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
- •Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.
排除标准
- •Previous intra-ocular surgery other than cataract surgery
- •Retinal detachment
- •Use of anticoagulants drugs other than aspirin
- •Vitreous hemorrhage clearance at week-3 study period
- •History of previous thromboembolic events
研究组 & 干预措施
B
Active Comparator
Pars plana vitrectomy only
干预措施: pars plana vitrectomy (Procedure)
A
Experimental
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
干预措施: bevacizumab (Drug)
结局指标
主要结局
Intra- and postoperative intra-ocular bleeding
时间窗: 12 weeks
次要结局
- Visual acuity(12 weeks)
研究者
研究点 (1)
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