Uveitis Gene-Expression Profiling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jim Rosenbaum, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00874471
First received: April 1, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Uveitis is a group of troublesome diseases that collectively represent a cause of blindness comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. The investigators propose to create a data base on peripheral blood gene expression for patients with 3 of the most important diseases associated with uveitis: ankylosing spondylitis, sarcoidosis, and Behcet's disease. The investigators will quantitatively measure the expression of consistent alteration in peripheral blood from patients with more than 40,000 gene sequences using microarray gene chip technology. This approach is known to detect systemic immune-mediated disease. The investigators will use this data base to:

  1. Determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behcet's can be distinguished from a normal population or controls with the same systemic disease but no history of uveitis
  2. Determine if the profile of gene expression can distinguish infectious or idiopathic forms of uveitis from patients with spondylitis, sarcoidosis, or Behcet's
  3. Determine how this gene profile changes over time as episodic disease such as spondylitis or Behcet's activates or remits
  4. Correlate the changes in gene expression with the prognosis of the ocular inflammatory process.

The creation of a gene expression data base for patients with uveitis has the potential to clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for predicting prognosis.


Condition
Uveitis

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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Correlation of blood transcriptome with form of uveitis [ Time Frame: time of office visit for disease evaluation ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: June 2005
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
sarcoidosis
ankylosing spondylitis
Behcet's disease
toxoplasmosis
herpetic acute retinal necrosis
idiopathic uveitis
ankylosing spondylitis (no uveitis)
sarcoidosis (no uveitis)
Behcet's disease (no uveitis)
normal control

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals suffering from selected subtypes of uveitis, individuals suffering from selected autoimmune disease and healthy individuals.

Criteria

Inclusion Criteria:

  • The study group will include patients aged 21 years or older attending the Uveitis Clinic at the Casey Eye Institute at OHSU who have uveitis of the following subtypes:

    1. ankylosing spondylitis
    2. sarcoidosis
    3. Behçet's disease
    4. toxoplasmosis
    5. herpetic acute retinal necrosis; AND
    6. idiopathic uveitis
  • Another group of patients, also aged 21 years or more, with the following diseases but no uveitis, will be recruited from the Rheumatology Clinic at OHSU as follows:

    1. ankylosing spondylitis
    2. sarcoidosis; AND
    3. Behçet's disease
  • The study group will also include 30 normal control volunteers aged 21 years or older.

Exclusion Criteria:

  • Special/vulnerable subject populations (e.g., mentally impaired persons and children) will not be enrolled.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874471

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: James Rosenbaum, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jim Rosenbaum, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00874471     History of Changes
Other Study ID Numbers: R01EY015858
Study First Received: April 1, 2009
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on April 23, 2014