Vitreous Levels of Cysteine-rich 61 in Patients With Proliferative Diabetic Retinopathy (VL)
|ClinicalTrials.gov Identifier: NCT01920984|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy||Drug: intravitreal injection of 1.25 mg of bevacizumab||Not Applicable|
Angiogenesis, the growth and proliferation of new blood vessels, is an important aspect of the vascular proliferation found in tumor growth, wound repair, inflammatory states, and ischemic sequel in the ocular angiogenetic diseases. Intraocular neovascularization, the major eventually complication of diabetic mellitus, may result in vitreous hemorrhage, tractional retinal detachment, neovascularization glaucoma and eventually blindness. The involved factors include basic fibroblast growth factor (bFGF), insulin-like growth factor-I (IGF-I), vascular endothelial cell growth factor (VEGF), and Connective tissue growth factor (CTGF)/Cysteine-rich protein (Cyr61)/Nephroblastoma overexpressed gene (CCN) family. VEGF is a primary angiogenic factor that mediates ischemic-induced retinal neovascularization. VEGF level are elevated in the vitreous fluid in patients with proliferative diabetic retinopathy (PDR). The unselective anti-VEGF antibody bevacizumab has been used for the treatment of diabetic retinopathy.
In spite of its potent anti-VEGF property, it does not completely inhibit ischemia-induced retinal neovascularization. Several other factors which were detected to have increased vitreous levels in the PDR patients might participate in the angiogenic process of diabetic retinopathy. One of the member of the CCN family, connective tissue growth factor (CTGF), was found to be involved in the angiogenesis and fibrosis mechanism of PDR. It is unclear if the other factors in the CCN family might also control the development of retinal angiogenesis and fibrosis.We measured vitreous cysteine-rich 61 (Cyr61) levels in PDR patients, non-diabetic patients,and PDR patients pretreated with bevacizumab. We further correlated the cysteine-rich 61 levels with different stages of PDR. Concomitant VEGF level was also measured to better understand the interaction of different factors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Vitreous Levels of Cysteine-rich 61 in Patients With Proliferative Diabetic Retinopathy|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Experimental: pretreatment of bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy due to diabetic retinopathy.
Drug: intravitreal injection of 1.25 mg of bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
Other Name: Bevacizumab(Avastin, Genentech, Inc., South San Francisco)
No Intervention: No pretreatment of bevacizumab
Patients will not receive bevacizumab pretreatment before vitreous surgery.
- Vitreous levels of Fractalkine, Cyr61, and VEGF of patients with proliferative diabetic retinopathy [ Time Frame: 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920984
|Department of Ophthalmology, National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chung-Hao Yang, MD, PhD||National Taiwan University Hospital|