Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Phase 2

• Conditions: Recurrent; Hemorrhage
• Interventions: Procedure: bevacizumab injection

• Registration Number: NCT01151722
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-25
• Last Update Submitted: 2010-06-25
• Study First Posted: 2010-06-28
• Last Update Posted: 2010-06-28
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental 3	bevacizumab injection	bevacizumab after vitrectomy
experimental 2	bevacizumab injection	bevacizumab before vitrectomy

Primary Outcome Measures

Name	Time	Method
Vitreous hemorrhage recurrence	3 months

Trial Locations

Locations (1)

Hospital das Clínicas de Ribeirão Preto - University of São Paulo; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil