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OpenTrials
Completed

NCT Number: NCT00423059

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Primary outcomes

  1. expression level of VEFG

  2. PEDG

  3. Factor VIII

Secondary outcomes

  1. complication rate

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jan 17, 2007
Registry last updated
Mar 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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