Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00423059
First received: January 16, 2007
Last updated: March 12, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention
Diabetic Retinopathy
Drug: bevacizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • expression level of VEFG
  • PEDG
  • Factor VIII

Secondary Outcome Measures:
  • complication rate

Estimated Enrollment: 20
Study Start Date: December 2006
Estimated Study Completion Date: March 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423059

Locations
Korea, Republic of
Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyoung Jun Koh Department of Ophthalmology, Yonsei University College of Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00423059     History of Changes
Other Study ID Numbers: koh01
Study First Received: January 16, 2007
Last Updated: March 12, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
intravitreal bevacizumab
proliferative diabetic retinopathy
VEGF
PEDF

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014