Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

University of Sao Paulo20 enrolled

Overview

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Retinopathy Retinal Detachment

Interventions

BevacizumabDRUG

Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline

pars plana vitrectomyPROCEDURE

pars plana vitrectomy 3 weeks after baseline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy. Exclusion Criteria: * Massive vitreous hemorrhage preventing from detailed posterior pole examination; * Previous intra-ocular surgery other than cataract surgery * Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin * Prothrombin time, partial thromboplastin time or platelet count without normal limits * History of previous thromboembolic events

Locations (1)

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

amount of intraoperative intra-ocular bleeding

Time frame: three weeks

Data from ClinicalTrials.gov

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