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
About this trial
This is an interventional prevention trial for Recurrent
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
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
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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