Use of Immune Cell Markers, Cytokines, Transcription Factors and Surface CD Markers as Markers of Ocular Inflammatory Activity
Data Collection
Eye Diseases
+ Uveal Diseases
+ Uveitis
Summary
Study start date: August 9, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* INCLUSION CRITERIA: * Patients with bilateral sight threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Disease can be active or quiescent, but subjects must be on a minimum prescribed therapy upon enrollment of a dose averaging at least 20 mg/day (or greater than or equal to 0.25 mg/kg/day) of systemic prednisone or a more intensive immunosuppression regimen. More intensive regimens may include from one to three anti-inflammatory treatments for uveitis that include any one of the following (or related) compounds: corticosteroids (including systemic or periorbital administration), topical corticosteroids (when used in combination with other agents), cyclophosphamide, cyclosporine, azathioprine, chlorambucil, tacrolimus, leflunomide, mycophenolate mofetil, or methotrexate. * Patients who have non-infectious intermediate, posterior, or panuveitis of at least 3 months duration. Included conditions may include but are not limited to intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis and sympathetic ophthalmia. * Patients who are 18 years of age or older. EXCLUSION CRITERIA: Subjects will not be able to enroll if they: * Are unwilling or unable to give blood at the designated times in the protocol. * Have another disease or condition affecting vision that will interfere with obtaining study data * Are pregnant
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps