Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Recurrent vitreous hemorrhage incidence after vitrectomy
研究概览
简要总结
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
详细描述
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
排除标准
- •follow-up period of less than 3 months
- •not first vitrectomy
- •abnormal blood coagulation
- •uncontrolled hypertension
研究组 & 干预措施
2- bevacizumab before vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
干预措施: bevacizumab (Drug)
3- bevacizumab after vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
干预措施: bevacizumab (Drug)
结局指标
主要结局
Recurrent vitreous hemorrhage incidence after vitrectomy
时间窗: 3 months
次要结局
- Visual outcome(3 months)