Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study
NCT00116090 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is not enough to control the diseases. Researchers expect to gain information about whether immunosuppressive therapy is suitable for patients and which substances should be avoided. Also, the study will evaluate the frequency of short-term complications with immunosuppressive therapy as well as benefits that the therapy can bring to treatment of eye diseases. The medical charts of patients up to age 65 (median age range of 21 to 65) who have had an inflammatory, noninfectious eye disease may be examined for this study. A database will be constructed through a chart review of patients seen in the uveitis clinic of the National Eye Institute since 1977 and three other sites. Patients who are considered exposed to immunosuppressive therapies will be compared with two groups: the general U.S. population and an internal group of patients with the same inflammatory eye diseases who did not receive immunosuppression. Data regarding about 10,000 to 15,000 patients will be collected. Patients will not be identified by the chart reviews. The incidence of cancer will be examined as well as the outcomes of immosuppressive therapy as measured by control of the eye disease, visual sharpness, changes in the use of corticosteroids, and rates of remission-when disease symptoms are lessened. Also examined will be medical charts of a control group of patients who did not receive immunosuppressive therapy for their uveitis. Data on cancer incidence would be more difficult to obtain, requiring personal contact with patients. In such situations, patients will be contacted by phone or mail, and those providing informed consent will be a
Conditions Studied
Study Locations (4)
Maryland
- Johns Hopkins University — Baltimore
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Massachusetts
- Massachusetts Eye and Ear Infirmary — Boston
Oregon
- Oregon Health Sciences University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,300 participants |
| Start Date | 2005-06-16 |
| Est. Completion | 2008-04-21 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00116090
The ClinicalTrials.gov registry entry for NCT00116090 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 214 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00116090 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Maryland, Massachusetts, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00116090 about?
NCT00116090 is a clinical study titled "Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study". This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding dise...
What is the current status of trial NCT00116090?
This trial is currently completed. The enrollment target is 6,300 participants. The study started on 2005-06-16. Estimated completion is 2008-04-21.
What conditions does trial NCT00116090 study?
This clinical trial studies the following conditions: Cancer, Infection, Uveitis, Immunosuppression, Mortality. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00116090?
This trial is sponsored by National Eye Institute (NEI), which has 214 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00116090 being conducted?
This trial has 4 study locations across Maryland, Massachusetts, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.