Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy (IBDV)

Seoul National University

Status: Completed

Conditions: Proliferative Diabetic Retinopathy; Vitreous Hemorrhage

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00745498

B-0801-053-004

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.

Full description

Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and 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 intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.

To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Enrollment: 126 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)

Exclusion criteria

• Follow-up period of less than 6 months
• Intraoperative use of long-acting gas or silicone oil
• Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
• Not first vitrectomy
• Uncontrolled hypertension
• Medical history of abnormal blood coagulation
• Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 3 patient groups

Preop IVB

Experimental group

Description:

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy

Treatment:

Drug: Bevacizumab

Intraop IVB

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

No IVB

No Intervention group

Description:

Patients will not receive bevacizumab before nor during vitrectomy