Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2010
Shorter than 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
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 24, 2010
March 1, 2010
8 months
March 23, 2010
March 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent vitreous hemorrhage incidence after vitrectomy
3 months
Secondary Outcomes (1)
Visual outcome
3 months
Study Arms (3)
1 - no bevacizumab
NO INTERVENTIONPatients will not receive bevacizumab before nor during vitrectomy
2- bevacizumab before vitrectomy
EXPERIMENTALPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
3- bevacizumab after vitrectomy
EXPERIMENTALPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Interventions
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
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 (2)
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.
PMID: 17995982BACKGROUNDDervenis 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)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Almeida, MD
University of Sao Paulo
Central Study Contacts
Hospital das Clínicas de Ribeirão Preto - USP
CONTACT
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
March 23, 2010
First Posted
March 24, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Study Completion
March 1, 2011
Last Updated
March 24, 2010
Record last verified: 2010-03