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Clinical Trials/NCT00423059
NCT00423059
Completed
Not Applicable

Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)

Yonsei University1 site in 1 country20 target enrollmentDecember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Yonsei University
Enrollment
20
Locations
1
Primary Endpoint
expression level of VEFG
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
March 2007
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

expression level of VEFG

PEDG

Factor VIII

Secondary Outcomes

  • complication rate

Study Sites (1)

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