Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy; Retinal Detachment
Intervention: Bevacizumab (Drug); pars plana vitrectomy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: University of Sao Paulo
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.
Clinical Details
Official title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: amount of intraoperative intra-ocular bleeding
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP, Ribeirão Preto, São Paulo 14049-900, Brazil
Additional Information
Starting date: March 2008
Ending date: May 2008
Last updated: June 3, 2008
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