Preoperative Bevacizumab for Vitreous Hemorrhage
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy; Vitreous Hemorrhage
Intervention: bevacizumab (Drug); pars plana vitrectomy (Procedure)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
Daniel R Lucena, MD, Principal Investigator, Affiliation: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Overall contact:
Daniel R Lucena, MD, Phone: 55 16 3602-2323, Email: drlucena@hcrp.fmrp.usp.br
Summary
The purpose of this study is to determine whether preoperative intravitreal bevacizumab is
effective in reducing intra-operative and postoperative bleeding in diabetic patients
submitted to pars plana vitrectomy for vitreous hemorrhage.
Clinical Details
Official title: Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: intra- and postoperative intra-ocular bleeding
Secondary outcome: visual acuity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss
lasting more than three months in patients not previously treated and four months in
those previously LASER treated.
Exclusion Criteria:
- Previous intra-ocular surgery other than cataract surgery
- Retinal detachment
- Use of anticoagulants drugs other than aspirin
- Vitreous hemorrhage clearance at week-3 study period
- History of previous thromboembolic events
Locations and Contacts
Daniel R Lucena, MD, Phone: 55 16 3602-2323, Email: drlucena@hcrp.fmrp.usp.br
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP, Ribeirão Preto, São Paulo 14049-900, Brazil; Recruiting
Daniel R Lucena, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: November 2008
Last updated: June 2, 2008
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