This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: January 4, 2008
Last updated: October 2, 2008
Last verified: September 2008
The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

Condition Intervention Phase
Diabetic Retinopathy Vitreous Hemorrhage Drug: bevacizumab Procedure: pars plana vitrectomy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intra- and postoperative intra-ocular bleeding [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 12 weeks ]

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 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 day after baseline; pars plana vitrectomy 4 weeks after baseline
Other Name: Avastin
Active Comparator: B
Pars plana vitrectomy only
Procedure: pars plana vitrectomy
4 weeks after baseline


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

Inclusion Criteria:

  • Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.

Exclusion Criteria:

  • Previous intra-ocular surgery other than cataract surgery
  • Retinal detachment
  • Use of anticoagulants drugs other than aspirin
  • Vitreous hemorrhage clearance at week-3 study period
  • 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 identifier: NCT00596297

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
Principal Investigator: Daniel R Lucena, MD Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
  More Information

Responsible Party: Daniel da Rocha Lucena, Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo Identifier: NCT00596297     History of Changes
Other Study ID Numbers: IBEVI
Study First Received: January 4, 2008
Last Updated: October 2, 2008

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

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Vitreous Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
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 August 23, 2017