Preoperative Bevacizumab for Vitreous Hemorrhage

Phase 1

Completed

• Conditions: Diabetic Retinopathy; Vitreous Hemorrhage
• Interventions: Procedure: pars plana vitrectomy; Drug: bevacizumab

• Registration Number: NCT00596297
• Lead Sponsor: University of Sao Paulo

Brief Summary

The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-10-02
• Last Update Posted: 2008-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.

Exclusion Criteria

• Previous intra-ocular surgery other than cataract surgery
• Retinal detachment
• Use of anticoagulants drugs other than aspirin
• Vitreous hemorrhage clearance at week-3 study period
• History of previous thromboembolic events

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	pars plana vitrectomy	Pars plana vitrectomy only
A	bevacizumab	Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Primary Outcome Measures

Name	Time	Method
Intra- and postoperative intra-ocular bleeding	12 weeks

Secondary Outcome Measures

Name	Time	Method
Visual acuity	12 weeks

Trial Locations

Locations (1)

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil