Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Public ClinicalTrials.gov record NCT00876434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: * Uveitis is an inflammatory condition in which the patient's own immune system attacks the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated with immunosuppressive medications to reduce the inflammation and prevent vision loss. * Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug Administration (FDA) to prevent organ rejection following a kidney transplant. Researchers think that sirolimus may affect the part of the immune system that may be an important cause of uveitis, and may decrease the inflammation that causes uveitis. * In this study, sirolimus will be given as an injection under the outer layer of your eye. The FDA has permitted the investigational use of sirolimus for this study. Objectives: * To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis. * To see if sirolimus is an effective treatment for uveitis. Eligibility: * Patients 18 years of age and older with active uveitis in one or both eyes. If a patient has uveitis in both eyes, the one in which the inflammation is worse will be treated during the study. The vision in the study eye must be at least 20/400. * Patients must have good liver function, and must be willing to practice sun protection measures for 2 weeks following the treatment. Design: * Treatment with sirolimus in the study eye: * Antibiotic and numbing eye drops will be given before the sirolimus injection. * 1 dose of sirolimus will be injected directly into the subconjunctiva (white part of the eye). * Antibiotic drops will be given for topical application 3 times per day for 2 days after the injection. * Patients will be followed for 16 weeks after sirolimus injection (initial visit and follow-up visits in Weeks 2, 4, 8, 12, and 16). * Evaluations during the treatment period and follow-up visits: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Full medical and ophthalmic history, involving questionnaires and discussion with researchers. * Eye examination, dilation, and photography, including measurements of retinal thickness and fluorescent dye tests of blood flow in the eye. * Blood and urine tests. * Because of the increased risk of skin cancer associated with sirolimus, patients ...
Study identification
- NCT ID
- NCT00876434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2009
- Primary completion
- Feb 9, 2011
- Completion
- Feb 9, 2011
- Last update posted
- Jul 1, 2017
2009 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00876434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00876434 live on ClinicalTrials.gov.