Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti
Status:
Completed
Trial end date:
2011-02-10
Target enrollment:
Participant gender:
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 ...