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Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

Primary Purpose

Diabetic Retinopathy, Vitreous Hemorrhage

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
bevacizumab
pars plana vitrectomy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Vitreous Hemorrhage, Bevacizumab, pars plana vitrectomy, preoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Pars plana vitrectomy only

Outcomes

Primary Outcome Measures

Intra- and postoperative intra-ocular bleeding

Secondary Outcome Measures

Visual acuity

Full Information

First Posted
January 4, 2008
Last Updated
October 2, 2008
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00596297
Brief Title
Preoperative Bevacizumab for Vitreous Hemorrhage
Acronym
IBEVI
Official Title
Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Vitreous Hemorrhage
Keywords
Diabetic Retinopathy, Vitreous Hemorrhage, Bevacizumab, pars plana vitrectomy, preoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
Arm Title
B
Arm Type
Active Comparator
Arm Description
Pars plana vitrectomy only
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy
Intervention Description
4 weeks after baseline
Primary Outcome Measure Information:
Title
Intra- and postoperative intra-ocular bleeding
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Lucena, MD
Organizational Affiliation
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Preoperative Bevacizumab for Vitreous Hemorrhage

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