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临床试验/NCT00745498
NCT00745498已完成不适用

Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Recurrent VH Incidence (Early and Late)

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.

详细描述

Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and 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 intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.

To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)

排除标准

  • Follow-up period of less than 6 months
  • Intraoperative use of long-acting gas or silicone oil
  • Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
  • Not first vitrectomy
  • Uncontrolled hypertension
  • Medical history of abnormal blood coagulation
  • Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment

研究组 & 干预措施

Preop IVB

Experimental

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy

干预措施: Bevacizumab (Drug)

Intraop IVB

Experimental

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 VH Incidence (Early and Late)

时间窗: 6 months

Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring \<= 4 weeks and "late recurrent VH" was VH occurring \>4 weeks after surgery.

次要结局

  • Visual Outcome(6 months)
  • Initial Time of Vitreous Clearing (ITVC)(6 months)
  • Postoperative Resolution of Neovascularization(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyu Hyung Park

Associate Professor

Seoul National University Bundang Hospital

研究点 (1)

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