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NCT00596297 Clinical Trial

Preoperative Bevacizumab for Vitreous Hemorrhage

Diabetic Retinopathy Clinical Trial

— IBEVI  

Official title:
Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00596297
Other study ID # IBEVI
Secondary ID 7309/2007
Status Completed
Phase Phase 1/Phase 2
First received January 4, 2008
Last updated October 2, 2008
Start date November 2007
Est. completion date September 2008

Study information
Verified date September 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
Procedure:
• pars plana vitrectomy
4 weeks after baseline

Locations
Country Name City State
Brazil Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP Ribeirão Preto São Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
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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