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Sponsored by: |
University of Sao Paulo |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00596297 |
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.
Condition | Intervention | Phase |
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Diabetic Retinopathy Vitreous Hemorrhage |
Drug: bevacizumab Procedure: pars plana vitrectomy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab |
Enrollment: | 16 |
Study Start Date: | November 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
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Drug: bevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
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B: Active Comparator
Pars plana vitrectomy only
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Procedure: pars plana vitrectomy
4 weeks after baseline
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, São Paulo | |
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP | |
Ribeirão Preto, São Paulo, Brazil, 14049-900 |
Principal Investigator: | Daniel R Lucena, MD | Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP |
Responsible Party: | Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo ( Daniel da Rocha Lucena ) |
Study ID Numbers: | IBEVI, 7309/2007 |
Study First Received: | January 4, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00596297 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Diabetic Retinopathy Vitreous Hemorrhage Bevacizumab pars plana vitrectomy preoperative |
Eye Diseases Temazepam Vascular Diseases Diabetes Mellitus Endocrine System Diseases Bevacizumab Hemorrhage |
Angiogenesis Inhibitors Vitreous Hemorrhage Diabetic Angiopathies Diabetic Retinopathy Endocrinopathy Retinal Diseases Diabetes Complications |
Antineoplastic Agents Growth Substances Eye Diseases Physiological Effects of Drugs Vascular Diseases Diabetes Mellitus Endocrine System Diseases Bevacizumab Hemorrhage Angiogenesis Inhibitors Vitreous Hemorrhage |
Pharmacologic Actions Diabetic Angiopathies Diabetic Retinopathy Pathologic Processes Therapeutic Uses Eye Hemorrhage Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Retinal Diseases Diabetes Complications |