Sirolimus Injections for Autoimmune Scleritis
Public ClinicalTrials.gov record NCT01517074. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study to Investigate Subconjunctival Sirolimus for the Treatment of Active Autoimmune Non-Necrotizing Anterior Scleritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Autoimmune scleritis is an inflammatory disease that affects the white outer part of the eye. It is associated with immune system disorders like rheumatoid arthritis. It can cause blindness in severe cases. Most treatments for scleritis involve steroid or immune-suppressing drugs, but these can cause side effects in the whole body. Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune system from attacking the body. Researchers want to try giving sirolimus injections into the eye to treat severe scleritis. Objectives: To see if sirolimus is a safe and effective treatment for autoimmune scleritis. Eligibility: Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has not responded to standard treatments. Design: * Participants will be screened with a medical history, physical exam, and eye exam. Blood and urine samples will also be collected. * One eye will be selected as the study eye to receive injections. * Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8, 12, and 16). The injection will be given at the first visit. If the study eye responds to the treatment, participants may have injections in the other eye at the second visit. * If there is still inflammation after the first injection, or if the scleritis improves but then returns, participants may have a second injection at Week 4. * Injections will be monitored with blood tests and eye exams. * Participants may have study visits and injections for up to 1 year if the injections seem to be working.
Study identification
- NCT ID
- NCT01517074
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 5 participants
Conditions and interventions
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
- Jan 2012 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Jun 19, 2020
2012 – 2014
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 NCT01517074, 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 Jun 19, 2020 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01517074 live on ClinicalTrials.gov.