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NCT00876434 · ClinicalTrials.gov registry record · Phase 1
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
A Phase 1 study of Anterior Uveitis, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00876434: Completed Phase 1 study of Anterior Uveitis, sponsored by National Eye Institute (NEI).
NCT00876434 is a Phase 1 study of Anterior Uveitis that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00876434, a Phase 1 study of Anterior Uveitis, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
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 pre
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-04-01 |
| Est. Completion | 2011-02-10 |
| Phase | Phase 1 |
What the finished NCT00876434 record still lists
NCT00876434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Anterior Uveitis appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT00876434 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00876434 about?
NCT00876434 is a clinical study titled "Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti". 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 immuno...
What is the current status of trial NCT00876434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2009-04-01. Estimated completion is 2011-02-10.
What conditions does trial NCT00876434 study?
This clinical trial studies the following conditions: Anterior Uveitis.
What interventions are being tested in trial NCT00876434?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00876434?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00876434 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00876434's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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