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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

Phase 2
Conditions
Vitreous Hemorrhage Secondary to PDR
Interventions
Registration Number
NCT01091896
Lead Sponsor
University of Sao Paulo
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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
1
Inclusion Criteria
  • patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
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Exclusion Criteria
  • follow-up period of less than 3 months
  • not first vitrectomy
  • abnormal blood coagulation
  • uncontrolled hypertension
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2- bevacizumab before vitrectomybevacizumabPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
3- bevacizumab after vitrectomybevacizumabPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Primary Outcome Measures
NameTimeMethod
Recurrent vitreous hemorrhage incidence after vitrectomy3 months
Secondary Outcome Measures
NameTimeMethod
Visual outcome3 months

Trial Locations

Locations (1)

Hospital das Clínicas de Ribeirão Preto - University of São Paulo

🇧🇷

Ribeirão Preto, SP, Brazil

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