Anterior Uveitis Clinical Trial
Official title:
Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis
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 ...
Objective: Uveitis refers to intraocular inflammatory diseases that are an important cause of
visual loss. Standard systemic immunosuppressive medications for uveitis can cause
significant adverse effects and many patients continue to experience disease flare-ups.
Sirolimus suppresses cytokine-driven T-cell proliferation and thus, inhibits the production,
signaling and activity of many growth factors relevant to uveitis. Subconjunctival sirolimus
administration could reduce or eliminate the need for topical and/or systemic
immunosuppressive drugs that could result in reduced morbidity. This protocol will
investigate subconjunctival sirolimus as a possible treatment for active anterior uveitis.
Study Population: Five participants with active anterior uveitis will be initially accrued in
this study. Participants must require treatment for their uveitis with systemic and/or
topical anti-inflammatory medications at high frequency intervals [greater than or equal to
three times daily (T.I.D.)] or local steroid treatment (periocular steroid injections) is
contraindicated because of significant intraocular pressure (IOP) elevation with local
steroid treatments in the past (i.e., steroid responder), have at least a grade of 1+ for
anterior chamber cells and have visual acuity of at least 20/400 in the study eye. Up to
seven participants may be enrolled, as up to two participants may be accrued to replace
enrolled participants who withdraw from the study prior to receiving any study medication.
Design: This is a Phase I, non-randomized, prospective, uncontrolled single-center study to
evaluate subconjunctival sirolimus as a treatment for active anterior uveitis. All
participants will receive a single 30-microL (1,320 microg) subconjunctival sirolimus
injection in the study eye at baseline and will be followed for 16 weeks post-injection.
Outcome Measures: The primary outcome is the number of participants who experience at least a
2-step reduction in anterior chamber inflammation within four weeks post-injection. Secondary
outcomes include changes in visual acuity and anterior chamber inflammation grading, the
number of participants who experience a disease flare within the 16-week study duration and,
of the participants who experience a disease flare, the number of days to disease flare from
baseline. Secondary outcomes also include the presence or extent of cystoid macular edema.
;
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