Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

University of Sao Paulo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Vitreous Hemorrhage; Diabetic Retinopathy

Treatments: Drug: bevacizumab; Procedure: pars plana vitrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00596297

7309/2007

IBEVI

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

A

Experimental group

Description:

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Treatment:

Drug: bevacizumab

B

Active Comparator group

Description:

Pars plana vitrectomy only

Treatment:

Procedure: pars plana vitrectomy