Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

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Abstract

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.

Dates

Last Verified:	01/31/2010
First Submitted:	06/24/2010
Estimated Enrollment Submitted:	06/24/2010
First Posted:	06/27/2010
Last Update Submitted:	06/24/2010
Last Update Posted:	06/27/2010
Actual Study Start Date:	11/30/2009
Estimated Primary Completion Date:	11/30/2010

Condition or disease

Recurrent

Hemorrhage

Intervention/treatment

Procedure: experimental 2

Procedure: experimental 3

Phase

Phase 2

Arm Groups

Arm	Intervention/treatment
No Intervention: no injection no bevacizumab
Experimental: experimental 2 bevacizumab before vitrectomy	Procedure: experimental 2 bevacizumab injection before vitrectomy
Experimental: experimental 3 bevacizumab after vitrectomy	Procedure: experimental 3 bevacizumab injection after vitrectomy

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy Exclusion Criteria: - follow-up period of less than 3 months - not first vitrectomy - abnormal blood coagulation - uncontrolled hypertension

Outcome

Primary Outcome Measures

1. Vitreous hemorrhage recurrence [3 months]