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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00089739 |
This study will try to identify markers of immune activity in uveitis patients that correlate with the state of disease activity. Uveitis is a group of inflammatory eye diseases that can cause vision loss. The study will examine whether certain substances in the blood can predict a reactivation of disease before it occurs, and how therapy may influence the activity of these substances. Previous studies have found some possible markers called GITR (glucocorticoid induced TNF related family receptor), SOCS (suppressors of cytokine secretion), and interleukin-15. Markers such as these may help guide physicians in safely tapering medicines in uveitis patients.
Patients 18 years of age and older with sight-threatening uveitis may be eligible for this study. Participants are slowly tapered off their medicines when their disease is stable and there is no evidence of significant inflammation. If the disease remains inactive during tapering, all drug therapy is eventually stopped. Patients have eye examinations about every 1 to 3 months when the disease is quiet and every 2 to 4 weeks during flare-ups. Blood samples are drawn 2 to 3 times a year. In addition, patients may have the following procedures if needed:
Condition |
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GITR GITR Ligand Uveitis Immunosuppression Suppressor of Cytokine Secretion |
Study Type: | Observational |
Official Title: | Use of Immune Cell Markers, Cytokines, Transcription Factors and Surface CD Markers as Markers of Ocular Inflammatory Activity |
Estimated Enrollment: | 100 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | October 2008 |
Indicators of disease activity in supposed autoimmune conditions are actively being sought. We have already described the increased expression of GITR-glucocorticoid induced TNF-related family receptor during active disease and a decrease in its expression when disease activity diminishes. We have preliminary observations in uveitis patients to suggest that suppressors of cytokine activity (SOCS) 1, 3, and 5 may also be active during either a Th1 or Th2 mediated disease. We wish to see if there is a correlation between these markers and whether they can serve as an indicator of impending activation of disease before actual clinical disease, and how therapy may alter their expression. Patients with uveitis will receive standard evaluation and treatment for inflammatory uveitis under this protocol Blood will be drawn when specific clinical criteria are reached for correlation of potential markers with disease activity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Subjects will not be able to enroll if they:
Study ID Numbers: | 040260, 04-EI-0260 |
Study First Received: | August 11, 2004 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00089739 |
Health Authority: | United States: Federal Government |
Uveitis Suppressor of Cytokine Secretion GITR Immunosuppression |
GITR Ligand Uveitis Intraocular Inflammation |
Uveitis Eye Diseases Inflammation |
Uveal Diseases |