NIH Clinical Research Studies

Protocol Number: 04-EI-0260

Active Accrual, Protocols Recruiting New Patients

Title:
Use of Immune Cell Markers, Cytokines, and Transcription Factors as Markers of Intraocular Inflammatory Activity
Number:
04-EI-0260
Summary:
Background: 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.

Aims: Is it possible to identify markers of immune activation in the peripheral blood of uveitis patients that correlate with the state of the immune activity in the eye.

Methods: This will be an observational study with no treatment arms. Patients requiring therapy to treat their uveitis will be followed and treated subject to standard clinical practice and their markers will be described throughout their disease course.

Sponsoring Institute:
National Eye Institute (NEI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children

HIV Positive

Pregant or Nursing

Eligibility Criteria:
INCLUSION CRITERIA:

Patients with bilateral sight threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Patients can be entered into this study either when they have clinically active disease or when their disease is well controlled with systemic medication. Inactive disease would be a patient who eyes show less than or equal to a trace vitreous haze. Active disease would be a patient who has one or both eyes with greater than a trace haze or a decrease in visual acuity from baseline of at least 10 letters or more based on the EDTRS chart, due to sequelae of uveitis such as cystoid macular edema but not due to cataract.

EXCLUSION CRITERIA:

We would exclude patients who are unwilling or unable to give blood at the designated times in the protocol.

Special Instructions: Currently Not Provided
Keywords:
Uveitis
Suppressor of Cytokine Secretion
GITR
Immunosuppression
GITR Ligand
Recruitment Keywords:
Uveitis
Intraocular Inflammation
Conditions:
GITR
GITR Ligand
Uveitis
Immunosuppression
Suppressor of Cytokine Secretion
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Expression of glucocorticoid induced TNF receptor family related protein (GITR) on peripheral T cells from normal human donors and patients with non-infectious uveitis. J Autoimmun. 2003 Aug;21(1):83-92. PMID: 12892739

Active Accrual, Protocols Recruiting New Patients

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