Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Phase 2
Completed
- Conditions
- Diabetic RetinopathyRetinal Detachment
- Interventions
- Procedure: pars plana vitrectomy
- Registration Number
- NCT00690768
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Bevacizumab Preoperative Intravitreal bevacizumab and pars plana vitrectomy A pars plana vitrectomy Preoperative Intravitreal bevacizumab and pars plana vitrectomy B pars plana vitrectomy Pars plana vitrectomy only
- Primary Outcome Measures
Name Time Method amount of intraoperative intra-ocular bleeding three weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
🇧🇷Ribeirão Preto, São Paulo, Brazil