Clinical Trial: Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis

Brief 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: