Back to resultsAdjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
Primary Purpose
Vitreous Hemorrhage Secondary to PDR
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Bevacizumab
bevacizumab
Sponsored by
About this trial
This is an interventional prevention trial for Vitreous Hemorrhage Secondary to PDR focused on measuring bevacizumab, vitreous hemorrhage, diabetes mellitus
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
1 - no bevacizumab
2- bevacizumab before vitrectomy
3- bevacizumab after vitrectomy
Arm Description
Patients will not receive bevacizumab before nor during vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Outcomes
Primary Outcome Measures
Recurrent vitreous hemorrhage incidence after vitrectomy
Secondary Outcome Measures
Visual outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01091896
Brief Title
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
Official Title
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
Detailed Description
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Hemorrhage Secondary to PDR
Keywords
bevacizumab, vitreous hemorrhage, diabetes mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 - no bevacizumab
Arm Type
No Intervention
Arm Description
Patients will not receive bevacizumab before nor during vitrectomy
Arm Title
2- bevacizumab before vitrectomy
Arm Type
Experimental
Arm Description
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Arm Title
3- bevacizumab after vitrectomy
Arm Type
Experimental
Arm Description
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Primary Outcome Measure Information:
Title
Recurrent vitreous hemorrhage incidence after vitrectomy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual outcome
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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
Hospital das Clínicas de Ribeirão Preto - USP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Almeida, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto - University of São Paulo
City
Ribeirão Preto
State/Province
SP
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, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17995982
Citation
Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.
Results Reference
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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
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