Differences in Genes and Proteins in Active and Controlled Uveitis

NCT00357266 | Completed

• 2 other identifiers: 02009902-EI-0099
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine blood cells and other tissue samples from people with uveitis (eye inflammation) to try to gain a better understanding of this condition. It will look at 1) the differences in cells when uveitis is active and when it is under control; 2) the genes that control the functions of these cells during different stages of the condition; and 3) the proteins the cells make at these different stages. Patients 6 years of age or older with an eye inflammation of at least 8 weeks' duration may be eligible for this study. They must currently be enrolled in another NEI protocol for evaluation or treatment of uveitis. Participants will provide blood and possibly eye tissue samples as follows: Blood samples: Blood samples will be drawn, probably from an arm vein, during periods when the inflammation is bad and when it is quiet. No more than 60 mL (about 4 tablespoons) will be drawn at any visit, and no more than eight samples will be collected in 1 year. Tissue samples: For patients who require eye surgery, a sample of tissue or fluid that is removed as a routine part of surgery may be provided to investigators in this study for research purposes. Samples will be collected during patients' visits scheduled as part of their other protocol. The samples will be labeled with a special code number to preserve the patient's identity.

Conditions

Ocular Inflammatory Disease; Uveitis

Keywords

Uveitis; Interleukin 2; Interleukin 2 Receptor; Microarrays; Genetic Expression; Daclizumab; HAT; Zenapax; Proteins; RNA; Ocular Inflammatory Disease

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 6 or more years of age.
• Participant has a diagnosis of an ocular inflammatory disease of at least eight weeks' duration prior to enrollment, requiring medical treatment to control the ocular inflammation. This treatment must require using a corticosteroid (e.g., prednisone or equivalent) or an investigational treatment, or any combination of two or more anti-inflammatory treatments, including for example prednisone, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, etc. Participants are anticipated to have, but are not restricted to, the following conditions: scleritis, intermediate or posterior uveitis, intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, Behcet's disease, juvenile rheumatoid arthritis (JRA), retinal vasculitis or sympathetic ophthalmia.
• Participant is currently enrolled in another NEI protocol for one of the above (or related) conditions that requires periodic visits to NIH for treatment and/or evaluation.
• Participant is able to understand and sign an informed consent (or applicable assent) and if the participant is younger than the age 18 at enrollment, has a parent or legal guardian who is able to understand and sign a consent form on their behalf.

You may not qualify if:

• Participant is under the age of 6 years.
• Participant has inadequate vascular access to obtain a routine venous peripheral whole blood specimen totaling up to 50 mL at a single visit.
• Participants has an inadequate peripheral leukocyte count such that it would be unlikely to provide an adequate RNA sample. For this purpose, a total leukocyte count below 3 x 10(9)/L will exclude a participant at enrollment. Unless there is a recognized medical condition likely to reduce leukocyte counts, blood counts from a prior visit up to 5 weeks earlier may be used to determine eligibility for a first or subsequent sample collection. (A participant who initially enrolls with an adequate leukocyte count may remain enrolled if counts subsequently fall below the limit, but will not have blood samples drawn for this protocol until the leukocyte count recovers above the limit).

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Schena M, Shalon D, Davis RW, Brown PO. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science. 1995 Oct 20;270(5235):467-70. doi: 10.1126/science.270.5235.467.

  PMID: 7569999 BACKGROUND

MeSH Terms

Conditions

Uveitis; Diabetes Mellitus, Insulin-Dependent, 10

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: February 1, 2002
• Study Completion: October 24, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-10-24

Locations

US (1)