Diabetic Retinopathy Clinical Trial
— IBEVIOfficial title:
Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intra- and postoperative intra-ocular bleeding | 12 weeks | No | |
Secondary | Visual acuity | 12 weeks | No |
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