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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage (ABeVi)

U

University of Sao Paulo

Status and phase

Unknown
Phase 2

Conditions

Hemorrhage
Recurrent

Treatments

Procedure: bevacizumab injection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

2 estimated patients

Sex

All

Ages

18 to 80 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

2 participants in 3 patient groups

no injection
No Intervention group
Description:
no bevacizumab
experimental 2
Experimental group
Description:
bevacizumab before vitrectomy
Treatment:
Procedure: bevacizumab injection
Procedure: bevacizumab injection
experimental 3
Experimental group
Description:
bevacizumab after vitrectomy
Treatment:
Procedure: bevacizumab injection
Procedure: bevacizumab injection

Trial contacts and locations

1

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Central trial contact

Felipe Almeida

Data sourced from clinicaltrials.gov

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