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

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: May 30, 2008
Last updated: June 3, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Diabetic Retinopathy
Retinal Detachment
Drug: Bevacizumab
Procedure: pars plana vitrectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • amount of intraoperative intra-ocular bleeding [ Time Frame: three weeks ]

Enrollment: 20
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
Drug: Bevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
Other Name: Avastin
Procedure: pars plana vitrectomy
pars plana vitrectomy 3 weeks after baseline
Active Comparator: B
Pars plana vitrectomy only
Procedure: pars plana vitrectomy
pars plana vitrectomy 3 weeks after baseline


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00690768

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00690768     History of Changes
Other Study ID Numbers: IBETRA
Study First Received: May 30, 2008
Last Updated: June 3, 2008

Keywords provided by University of Sao Paulo:
Diabetic Retinopathy
Retinal detachment
Vitreous Hemorrhage
pars plana vitrectomy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017