Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti

Completed · Phase 1

Conditions studied: Anterior Uveitis

In brief

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 ...

Key facts

Study ID

NCT00876434

Run by

National Eye Institute (NEI)

People needed

5

Starts

2009-04-01

Expected to finish

2011-02-10

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections.
• Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years.
• Participant has used latanoprost (Xalatan (Registered Trademark)) within two weeks prior to study enrollment or is likely to need it at any point during the study as determined by the investigator.
• For participants with active anterior uveitis in both eyes, the participant's non-study eye is anticipated to require periocular steroids or it is anticipated that an increase in systemic immunosuppressive treatments including steroids may be required during the course of the study.
• Participant has a media opacity that precludes assessment of anterior chamber inflammation.
• Participant has active joint or systemic inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.