Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

October 2, 2008 updated by: University of Sao Paulo

Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Avastin
Active Comparator: B
Pars plana vitrectomy only
Procedure: pars plana vitrectomy
4 weeks after baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra- and postoperative intra-ocular bleeding
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

October 3, 2008

Last Update Submitted That Met QC Criteria

October 2, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBEVI
  • 7309/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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