Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Not Applicable

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT00423059
• Lead Sponsor: Yonsei University

Brief Summary

Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with its pharmacologic blockade of VEGF.

The purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation.

The patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. The one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. The fibrovascular membrane will be excised during surgery and fixated for histologic examinations. The expression of VEGF and PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. The results will be compared between two treatment groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Status Verified: 2007-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-17
• Study Completion: 2007-03
• Last Update Submitted: 2007-03-12
• Last Update Posted: 2007-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
• Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation

Exclusion Criteria

• Uncontrolled systemic hypertension
• Recent history of myocardiac infarction within 6 months
• Recent history of cerebrovascular accident within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
expression level of VEFG
PEDG
Factor VIII

Secondary Outcome Measures

Name	Time	Method
complication rate

Trial Locations

Locations (1)

Department of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of