Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

Not Applicable

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Bevacizumab

• Registration Number: NCT00524875
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Detailed Description

Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2007-08
• Study Completion: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Last Update Submitted: 2007-09-04
• Study First Posted: 2007-09-05
• Last Update Posted: 2007-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

Exclusion Criteria

• One eye patient
• Best corrected visual acuity better than 20/50
• Pregnancy
• Use of internal tamponade such as silicone oil during surgery
• Concurrent ophthalmic surgery such as cataract extraction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab	Intravitreal bevacizumab injection 1-2 weeks before surgery
2	Bevacizumab	Sham injection (needleless syringe pressed against conjunctiva)

Primary Outcome Measures

Name	Time	Method
early post-vitrectomy vitreous hemorrhage

Secondary Outcome Measures

Name	Time	Method
Visual improvement

Trial Locations

Locations (1)

Hamid Ahmadieh, MD; 🇮🇷 Tehran, Iran, Islamic Republic of