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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage (ABeVi)

Primary Purpose

Recurrent, Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
bevacizumab injection
bevacizumab injection
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

  • follow-up period of less than 3 months
  • not first vitrectomy
  • abnormal blood coagulation
  • uncontrolled hypertension

Sites / Locations

  • Hospital das Clínicas de Ribeirão Preto - University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

no injection

experimental 2

experimental 3

Arm Description

no bevacizumab

bevacizumab before vitrectomy

bevacizumab after vitrectomy

Outcomes

Primary Outcome Measures

Vitreous hemorrhage recurrence

Secondary Outcome Measures

Full Information

First Posted
June 25, 2010
Last Updated
June 25, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01151722
Brief Title
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
Acronym
ABeVi
Official Title
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery. We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent, Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
no injection
Arm Type
No Intervention
Arm Description
no bevacizumab
Arm Title
experimental 2
Arm Type
Experimental
Arm Description
bevacizumab before vitrectomy
Arm Title
experimental 3
Arm Type
Experimental
Arm Description
bevacizumab after vitrectomy
Intervention Type
Procedure
Intervention Name(s)
bevacizumab injection
Intervention Description
bevacizumab injection before vitrectomy
Intervention Type
Procedure
Intervention Name(s)
bevacizumab injection
Intervention Description
bevacizumab injection after vitrectomy
Primary Outcome Measure Information:
Title
Vitreous hemorrhage recurrence
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy Exclusion Criteria: follow-up period of less than 3 months not first vitrectomy abnormal blood coagulation uncontrolled hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe Almeida
Email
felipeppalmeida@yahoo.com.br
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto - University of São Paulo
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-990
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Almeida, MD
Phone
16 3602-2523
Ext
2523
Email
felipeppalmeida@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Felipe Almeida
First Name & Middle Initial & Last Name & Degree
Felipe Almeida, MD

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

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