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Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy

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Seoul National University Bundang Hospital

关键词

抽象

The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

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.

日期

最后验证: 10/31/2015
首次提交: 09/01/2008
提交的预估入学人数: 09/01/2008
首次发布: 09/02/2008
上次提交的更新: 11/16/2015
最近更新发布: 12/20/2015
首次提交结果的日期: 06/05/2012
首次提交质量检查结果的日期: 11/16/2015
首次发布结果的日期: 12/20/2015
实际学习开始日期: 05/31/2008
预计主要完成日期: 09/30/2010
预计完成日期: 09/30/2010

状况或疾病

Proliferative Diabetic Retinopathy
Vitreous Hemorrhage

干预/治疗

Drug: Bevacizumab

-

手臂组

干预/治疗
Experimental: Preop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy
Experimental: Intraop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
No Intervention: No IVB
Patients will not receive bevacizumab before nor during vitrectomy

资格标准

有资格学习的年龄 20 Years 至 20 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

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

Exclusion Criteria:

- 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

结果

主要结果指标

1. Recurrent VH Incidence (Early and Late) [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.

次要成果指标

1. Initial Time of Vitreous Clearing (ITVC) [6 months]

The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.

2. Visual Outcome [6 months]

Best-corrected visual acuity (BCVA) at postoperative 6 months

3. Postoperative Resolution of Neovascularization [6 months]

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