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

This study has been completed.

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00690768

First received: May 30, 2008

Last updated: June 3, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	May 30, 2008
Last Updated Date	June 3, 2008
Start Date ^ICMJE	March 2008
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 3, 2008)	amount of intraoperative intra-ocular bleeding [ Time Frame: three weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00690768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Official Title ^ICMJE	Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetic Retinopathy Retinal Detachment
Intervention ^ICMJE	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
Study Arm (s)	Experimental: A Preoperative Intravitreal bevacizumab and pars plana vitrectomy Interventions: Drug: Bevacizumab Procedure: pars plana vitrectomy Active Comparator: B Pars plana vitrectomy only Intervention: Procedure: pars plana vitrectomy
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	May 2008
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT00690768
Other Study ID Numbers ^ICMJE	IBETRA
Has Data Monitoring Committee	No
Responsible Party
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of Sao Paulo
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top