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NCT01151722 Clinical Trial

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Hemorrhage Clinical Trial

— ABeVi  

Official title:
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01151722
Other study ID # HCRP22
Secondary ID
Status Recruiting
Phase Phase 2
First received June 25, 2010
Last updated June 25, 2010
Start date December 2009

Study information
Verified date February 2010
Source University of Sao Paulo
Contact Felipe Almeida
Email felipeppalmeida@yahoo.com.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

Recruitment information / eligibility
Status Recruiting
Enrollment 2
Est. completion date
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

- follow-up period of less than 3 months

- not first vitrectomy

- abnormal blood coagulation

- uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• bevacizumab injection
bevacizumab injection before vitrectomy
• bevacizumab injection
bevacizumab injection after vitrectomy

Locations
Country Name City State
Brazil Hospital das Clínicas de Ribeirão Preto - University of São Paulo Ribeirão Preto Sao 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 Vitreous hemorrhage recurrence 3 months No
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