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Clinical Trials/NCT01091896
NCT01091896
Unknown
Phase 2

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy

University of Sao Paulo1 site in 1 country1 target enrollmentJanuary 2010

Overview

Phase
Phase 2
Intervention
bevacizumab
Conditions
Vitreous Hemorrhage Secondary to PDR
Sponsor
University of Sao Paulo
Enrollment
1
Locations
1
Primary Endpoint
Recurrent vitreous hemorrhage incidence after vitrectomy
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.

Detailed Description

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
March 2011
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

2- bevacizumab before vitrectomy

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy

Intervention: bevacizumab

3- bevacizumab after vitrectomy

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Intervention: bevacizumab

Outcomes

Primary Outcomes

Recurrent vitreous hemorrhage incidence after vitrectomy

Time Frame: 3 months

Secondary Outcomes

  • Visual outcome(3 months)

Study Sites (1)

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