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The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yeşim Gedik Oğuz, Turkish Ophthalmology Society
ClinicalTrials.gov Identifier:
NCT01720628
First received: October 23, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.

Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.


Condition Intervention
Behçet's Disease
 Other: serum levels of angiogenin, bFGF, VEGF

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turkish Ophthalmology Society:

Primary Outcome Measures:
  • Serum levels of angiogenin in Behçet's patients with or without ocular involvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance.


Secondary Outcome Measures:
  • Serum levels of bFGF in Behçet's patients with or without ocular involvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Serum levels of VEGF in Behçet's patients with or without ocular involvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum


Enrollment: 86
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Behçet's patients
Serum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group
 Other: serum levels of angiogenin, bFGF, VEGF
Behçet's patients

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Turkish patients fulfilling the international diagnostic criteria for Behçet's disease

Criteria

Inclusion Criteria:

  • age between 18-65
  • fulfilling the international diagnostic criteria for Behçet's disease

Exclusion Criteria:

  • to have another systemic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720628

Locations
Turkey
Ankara University, Faculty of Medicine, Department of Ophthalmology
Ankara, Turkey, 06620
Sponsors and Collaborators
Turkish Ophthalmology Society
Investigators
Study Director: ali yalçındağ * Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry
  More Information

No publications provided

Responsible Party: Yeşim Gedik Oğuz, MD, Turkish Ophthalmology Society
ClinicalTrials.gov Identifier: NCT01720628     History of Changes
Other Study ID Numbers: AFV-5813
Study First Received: October 23, 2012
Last Updated: October 31, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Turkish Ophthalmology Society:
Angiogenin, Behçet's disease, bFGF, VEGF

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
 Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Angiogenin
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013