Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089739
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-08-11
Brief Title:
Immune Indicators of Uveitis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Use of Immune Cell Markers Cytokines Transcription Factors and Surface CD Markers as Markers of Ocular Inflammatory Activity
Status:
COMPLETED
Status Verified Date:
2008-10-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Eye photography Eye drops are given to enlarge the pupils for a thorough eye examination and a special camera is used to take photographs
Fluorescein angiography This test checks for abnormalities of eye blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes Pictures of the retina are taken with a special camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible abnormalities
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
Eye photography Eye drops are given to enlarge the pupils for a thorough eye examination and a special camera is used to take photographs
Fluorescein angiography This test checks for abnormalities of eye blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes Pictures of the retina are taken with a special camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible abnormalities
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-EI-0260 | None | None | None |