Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
关键词
抽象
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
干预/治疗
Drug: Bevacizumab
相
手臂组
臂 | 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 | 是 |
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]
次要成果指标
1. Initial Time of Vitreous Clearing (ITVC) [6 months]
2. Visual Outcome [6 months]
3. Postoperative Resolution of Neovascularization [6 months]