Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF, PEDF
Eligibility 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
Sites / Locations
- Department of Ophthalmology, Yonsei University College of Medicine
Outcomes
Primary Outcome Measures
expression level of VEFG
PEDG
Factor VIII
Secondary Outcome Measures
complication rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00423059
Brief Title
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Official Title
Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF, PEDF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Primary Outcome Measure Information:
Title
expression level of VEFG
Title
PEDG
Title
Factor VIII
Secondary Outcome Measure Information:
Title
complication rate
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jun Koh
Organizational Affiliation
Department of Ophthalmology, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
16829817
Citation
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.
Results Reference
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PubMed Identifier
17011869
Citation
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.
Results Reference
background
PubMed Identifier
16604386
Citation
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.
Results Reference
background
PubMed Identifier
17011951
Citation
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.
Results Reference
background
PubMed Identifier
16815267
Citation
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.
Results Reference
background
PubMed Identifier
16680105
Citation
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.
Results Reference
background
PubMed Identifier
16508426
Citation
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.
Results Reference
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Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
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