Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423059
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : March 13, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: bevacizumab Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)
Study Start Date : December 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. expression level of VEFG
  2. PEDG
  3. Factor VIII

Secondary Outcome Measures :
  1. complication rate

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423059

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

Publications: Identifier: NCT00423059     History of Changes
Other Study ID Numbers: koh01
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: January 2007

Keywords provided by Yonsei University:
intravitreal bevacizumab
proliferative diabetic retinopathy

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