Uveitis Gene-Expression Profiling

Uveitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874471
• Other study ID #: R01EY015858
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: April 7, 2014
• Start date: June 2005

Study information

• Verified date: April 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of blood transcriptome with form of uveitis		time of office visit for disease evaluation	No