Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy - Full Text View

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:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab

U.S. FDA Resources

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:

Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. No abstract available.

Mason JO 3rd, Nixon PA, White MF. Intravitreal injection of bevacizumab (Avastin) as adjunctive treatment of proliferative diabetic retinopathy. Am J Ophthalmol. 2006 Oct;142(4):685-8.

Matsuoka M, Ogata N, Minamino K, Matsumura M. Expression of pigment epithelium-derived factor and vascular endothelial growth factor in fibrovascular membranes from patients with proliferative diabetic retinopathy. Jpn J Ophthalmol. 2006 Mar-Apr;50(2):116-20.

Avery RL, Pearlman J, Pieramici DJ, Rabena MD, Castellarin AA, Nasir MA, Giust MJ, Wendel R, Patel A. Intravitreal bevacizumab (Avastin) in the treatment of proliferative diabetic retinopathy. Ophthalmology. 2006 Oct;113(10):1695.e1-15.

Oshima Y, Sakaguchi H, Gomi F, Tano Y. Regression of iris neovascularization after intravitreal injection of bevacizumab in patients with proliferative diabetic retinopathy. Am J Ophthalmol. 2006 Jul;142(1):155-8.

Bakri SJ, Donaldson MJ, Link TP. Rapid regression of disc neovascularization in a patient with proliferative diabetic retinopathy following adjunctive intravitreal bevacizumab. Eye. 2006 Dec;20(12):1474-5. Epub 2006 May 5. No abstract available.

Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8.

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 May 21, 2013