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
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Dissociative Disorders
Retinal Detachment
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Mental Disorders
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014