Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
ABeVi
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedJune 28, 2010
February 1, 2010
1 year
June 25, 2010
June 25, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Vitreous hemorrhage recurrence
3 months
Study Arms (3)
no injection
NO INTERVENTIONno bevacizumab
experimental 2
EXPERIMENTALbevacizumab before vitrectomy
experimental 3
EXPERIMENTALbevacizumab after vitrectomy
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
You may not qualify if:
- follow-up period of less than 3 months
- not first vitrectomy
- abnormal blood coagulation
- uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas de Ribeirão Preto - University of São Paulo
Ribeirão Preto, São Paulo, 14049-990, Brazil
Related Publications (1)
Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
PMID: 37260074DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 25, 2010
First Posted
June 28, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Last Updated
June 28, 2010
Record last verified: 2010-02