Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

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

NCT01091896

IBEViH

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

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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