Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

NCT00423059 | Completed

• 1 other identifier: koh01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

intravitreal bevacizumab; proliferative diabetic retinopathy; VEGF; PEDF

Outcome Measures

Primary Outcomes (3)

• expression level of VEFG

• PEDG

• Factor VIII

Secondary Outcomes (1)

• complication rate

Interventions

bevacizumab DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
• Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation

You may not qualify if:

• Uncontrolled systemic hypertension
• Recent history of myocardiac infarction within 6 months
• Recent history of cerebrovascular accident within 6 months

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (7)

• 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. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.

  PMID: 16829817 BACKGROUND

• 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. doi: 10.1016/j.ajo.2006.04.058.

  PMID: 17011869 BACKGROUND

• 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. doi: 10.1007/s10384-005-0294-9.

  PMID: 16604386 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2006.05.064.

  PMID: 17011951 BACKGROUND

• 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. doi: 10.1016/j.ajo.2006.02.015.

  PMID: 16815267 BACKGROUND

• Bakri SJ, Donaldson MJ, Link TP. Rapid regression of disc neovascularization in a patient with proliferative diabetic retinopathy following adjunctive intravitreal bevacizumab. Eye (Lond). 2006 Dec;20(12):1474-5. doi: 10.1038/sj.eye.6702364. Epub 2006 May 5. No abstract available.

  PMID: 16680105 BACKGROUND

• Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.

  PMID: 16508426 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hyoung Jun Koh

  Department of Ophthalmology, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 17, 2007
• Study Start: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 13, 2007

Record last verified: 2007-01

Locations

KR (1)