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Vitreous Levels of Cysteine-rich 61 in Patients With Proliferative Diabetic Retinopathy (VL)

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ClinicalTrials.gov Identifier: NCT01920984
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in patients with PDR. Verifying that it is greater to that found in non-diabetic patients with different non-angiogenetic diseases.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: intravitreal injection of 1.25 mg of bevacizumab Not Applicable

Detailed Description:

Introduction:

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.

Problem:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Vitreous levels of Fractalkine, Cyr61, and VEGF of patients with proliferative diabetic retinopathy [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with type 1 or type 2 diabetes mellitus
  • Not eligible for any currently approved treatments or experimental protocols
  • Patients with PDR who receiving vitreoretinal surgery.

Exclusion Criteria:

  • A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure
  • Panretinal laser photocoagulation in the study eye
  • Previous treatment with intravitreal or sub-Tenon triamcinolone
  • History of submacular surgery or other surgical intervention for diabetic

Information from the National Library of Medicine

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): NCT01920984


Locations
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Taiwan
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chung-Hao Yang, MD, PhD National Taiwan University Hospital

Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01920984     History of Changes
Other Study ID Numbers: NSC96-2628-B-002-032-MY3
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: January 2004

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors