Status:
COMPLETED
Differences in Genes and Proteins in Active and Controlled Uveitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Ocular Inflammatory Disease
Uveitis
Eligibility:
All Genders
6+ years
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 ...
Detailed Description
Ocular inflammatory diseases, including uveitis, cause significant visual loss. Previous non-human investigations have identified several cell types, receptor systems and metabolic intermediates that ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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).
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
OBSERVATIONAL
End Date :
October 24 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00357266
Start Date
February 1 2002
End Date
October 24 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892