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Sirolimus Injections for Autoimmune Scleritis

NCT01517074 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-06-19

Study results available
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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.

Conditions

  • Scleritis

Interventions

DRUG

Sirolimus

Subconjunctival injection

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Hatice N Sen, M.D. · National Eye Institute (NEI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-05-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517074 on ClinicalTrials.gov