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临床试验/NCT01151722
NCT01151722Unknown2 期

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
2 期
入组人数
2
试验地点
2
主要终点
Vitreous hemorrhage recurrence

研究概览

简要总结

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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

结局指标

主要结局

Vitreous hemorrhage recurrence

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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