Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
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|ClinicalTrials.gov Identifier: NCT00423059|
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : March 13, 2007
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|
|Diabetic Retinopathy||Drug: bevacizumab|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)|
|Study Start Date :||December 2006|
|Estimated Study Completion Date :||March 2007|
- expression level of VEFG
- Factor VIII
- complication rate
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 ClinicalTrials.gov identifier (NCT number): NCT00423059
|Korea, Republic of|
|Department of Ophthalmology, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Hyoung Jun Koh||Department of Ophthalmology, Yonsei University College of Medicine|