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

August 12, 2013 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Department of Ophthalmology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Bevacizumab(Avastin, Genentech, Inc., South San Francisco)
NO_INTERVENTION: No pretreatment of bevacizumab
Patients will not receive bevacizumab pretreatment before vitreous surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitreous levels of Fractalkine, Cyr61, and VEGF of patients with proliferative diabetic retinopathy
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chung-Hao Yang, MD, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (ESTIMATE)

August 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

January 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC96-2628-B-002-032-MY3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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