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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

U

University of Sao Paulo

Status and phase

Unknown
Phase 2

Conditions

Vitreous Hemorrhage Secondary to PDR

Treatments

Drug: Bevacizumab
Drug: bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

1 estimated patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 3 patient groups

1 - no bevacizumab
No Intervention group
Description:
Patients will not receive bevacizumab before nor during vitrectomy
2- bevacizumab before vitrectomy
Experimental group
Description:
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Treatment:
Drug: Bevacizumab
3- bevacizumab after vitrectomy
Experimental group
Description:
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Treatment:
Drug: bevacizumab

Trial contacts and locations

1

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Central trial contact

Hospital das Clínicas de Ribeirão Preto - USP

Data sourced from clinicaltrials.gov

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