NCT00745498

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Proliferative Diabetic Retinopathy
• Vitreous Hemorrhage

Interventions

Type	Name	Description
DRUG	Bevacizumab	Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-09-03
• Last updated: 2015-12-21
• Results posted: 2015-12-21

Locations

1 site across 1 country: South Korea