IBEVI: Preoperative Bevacizumab for Vitreous Hemorrhage

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00596297

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Vitreous Hemorrhage	Drug: bevacizumab Procedure: pars plana vitrectomy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Preoperative Intravitreal bevacizumab and pars plana vitrectomy	Drug: bevacizumab Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline Other Names: Avastin
Active Comparator: B Pars plana vitrectomy only	Procedure: pars plana vitrectomy 4 weeks after baseline

Arm

Intervention/Treatment

Experimental: A

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Drug: bevacizumab

Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline

Other Names:

Avastin

Active Comparator: B

Pars plana vitrectomy only

Procedure: pars plana vitrectomy

4 weeks after baseline

Outcome Measures

Primary Outcome Measures

Intra- and postoperative intra-ocular bleeding [12 weeks]

Secondary Outcome Measures

Visual acuity [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.