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

This study has been completed.

First Received: May 30, 2008 Last Updated: 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:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab Temazepam

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
A: Experimental 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 Procedure: pars plana vitrectomy pars plana vitrectomy 3 weeks after baseline
B: Active Comparator 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, São Paulo
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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	IBETRA
Study First Received:	May 30, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00690768 History of Changes
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:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Bevacizumab
Diabetic Angiopathies
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Diabetes Complications
Retinal Diseases

Tranquilizing Agents
Growth Substances
Eye Diseases
Temazepam
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Central Nervous System Depressants
Angiogenesis Inhibitors
Pharmacologic Actions
Retinal Detachment
Diabetic Retinopathy
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009