Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01517074 · ClinicalTrials.gov registry record · Phase 1
Sirolimus Injections for Autoimmune Scleritis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01517074 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT01517074, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01517074
The ClinicalTrials.gov registry entry for NCT01517074 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT01517074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01517074 about?
NCT01517074 is a clinical study titled "Sirolimus Injections for Autoimmune Scleritis". 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 t...
What is the current status of trial NCT01517074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-01. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01517074?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT01517074?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.