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

This study has been completed.

First Received on May 30, 2008. Last Updated on June 3, 2008 History of Changes

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00690768

Purpose

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

amount of intraoperative intra-ocular bleeding [ Time Frame: three weeks ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690768

Locations

Brazil
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

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. Epub 2009 Feb 10.

ClinicalTrials.gov Identifier:	NCT00690768 History of Changes
Other Study ID Numbers:	IBETRA
Study First Received:	May 30, 2008
Last Updated:	June 3, 2008
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

Diabetic Retinopathy
Retinal detachment
Vitreous Hemorrhage

Bevacizumab
preoperative
pars plana vitrectomy

Additional relevant MeSH terms:

Diabetic Retinopathy
Retinal Detachment
Retinal Diseases
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Temazepam
Bevacizumab
Anti-Anxiety Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 13, 2012