GITRNCT00089739
Immune Indicators of Uveitis
An observational study of GITR and GITR Ligand, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GITR, GITR Ligand, Uveitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2004to 28 Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Use of Immune Cell Markers, Cytokines, Transcription Factors and Surface CD Markers as Markers of Ocular Inflammatory Activity
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.
Read the 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.
- Conditions
- GITR, GITR Ligand, Uveitis, Immunosuppression, Suppressor of Cytokine Secretion
- Keywords
- Uveitis, Suppressor of Cytokine Secretion, GITR, Immunosuppression, GITR Ligand, Intraocular Inflammation
- Medical subject headings
- Uveitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study start9 Aug 2004
- Study completion28 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GITRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089739
- Sponsor's protocol ID
- 040260
- Other IDs
- 04-EI-0260
- Status last verified
- 28 Oct 2008
- First submitted
- 11 Aug 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Li Z, Mahesh SP, Kim BJ, Buggage RR, Nussenblatt RB. 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. doi: 10.1016/s0896-8411(03)00085-4.
PubMed 12892739
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Immune Cell Markers, Cytokines, Transcription Factors and Surface CD Markers as Markers of Ocular Inflammatory Activity
- ClinicalTrials.gov ID
- NCT00089739
- Acronym / sponsor ID
- 040260
- Conditions
- GITR, GITR Ligand, Uveitis, Immunosuppression, Suppressor of Cytokine Secretion
- Keywords
- Uveitis, Suppressor of Cytokine Secretion, GITR, Immunosuppression, GITR Ligand, Intraocular Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 9 Aug 2004
- Study completion
- 28 Oct 2008
- First posted
- 12 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12892739Li Z, Mahesh SP, Kim BJ, Buggage RR, Nussenblatt RB. 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. doi: 10.1016/s0896-8411(03)00085-4.
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GITR and GITR Ligand, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00089739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.