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

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Retinal Detachment; Diabetic Retinopathy

Treatments: Procedure: pars plana vitrectomy; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00690768

IBETRA

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

A

Experimental group

Description:

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Treatment:

Procedure: pars plana vitrectomy

Drug: Bevacizumab

B

Active Comparator group

Description:

Pars plana vitrectomy only

Treatment:

Procedure: pars plana vitrectomy