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Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti

NCT00876434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-07-02

No results posted yet for this 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 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 ...

Conditions

  • Anterior Uveitis

Interventions

DRUG

Sirolimus

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-01
Primary Completion
2011-02-10
Completion
2011-02-10

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 NCT00876434 on ClinicalTrials.gov