Clinical Trial: Intravitreal Sirolimus as Therapeutic Approach to Uveitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sirolimus as a Therapeutic Approach for Uveitis: A Phase 2, Open-label, Randomized Study to Assess the Safety, Tolerability, and Bioactivity of Two Doses of Intravitreal Injection of Sirolimus in Pati

Brief Summary: The purpose of this study is to find out about the safety and effectiveness of two different doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies. In this study, the investigators will administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or 880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.

Detailed Summary:

Uveitis is a condition in which certain parts of your eye become inflamed. The inflammation is usually recurrent. If the inflammation is not treated adequately, permanent damage to the eye and to the vision may occur. The inflammation can be caused by infectious or non infectious causes. The current research is being done to determine the safety and the usefulness of treatment of non-infectious uveitis using different doses of intravitreal injections of a drug called sirolimus.

Current treatment options for uveitis include oral corticosteroids and drugs that weaken the immune system of the body (i.e., immunosuppressant drugs). Treatment using oral corticosteroids, especially for long periods, may cause many undesirable side effects and complications such as high blood sugar, high blood pressure, bone weakness, obesity, stomach ulcers, abnormal hair growth, and increased risks of infection. In addition to that, in some cases, the disease cannot be controlled even with the highest dose of steroids.

Injection of steroids around and inside the eye can be used to control uveitis. However, the inflammation does not always respond to such kind of treatment. The eyes may develop high pressure and cataract with injections of steroids into the eyes or around the eyes.

On the other hand, despite their potential effectiveness, treatment with drugs that weaken the immune system may cause severe side effects. Increased risk of infection is a common side effect of all the immunosuppressant drugs. The immune system protects the body from infections. When the immune system is suppressed, infections are more likely to happen. Some of these infections are potentially dangerous. Because the immune system protects the body against some forms of cancer, immunosuppressant drugs are also associate
Sponsor: University of Nebraska

Current Primary Outcome: Frequency of uveitic attacks as assessed by vitreous haze and cells. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of adverse and serious adverse events [ Time Frame: 6 months ]
  Incidence, frequencey, and severity of adverse events reported during the first 6 months of the study period.
• Changes in central retinal thickness [ Time Frame: 6 months ]
  Improvement or worsening of macular edema compared to baseline. Development of macular edema in patients with otherwise normal macualr thickness at baseline
• Steroid sparing effect [ Time Frame: 6 months ]

  Proportion of subjects with active uveitis who achieve complete or partial response to sirolimus at month 6 while discontinuing their steroid therapy.

  Proportion of subjects with inactive uveitis who maintain quiscent study eyes at month 6 while discontinuing their steroid therapy.

Original Secondary Outcome: Same as current

Information By: University of Nebraska

Dates:
Date Received: January 20, 2011
Date Started: March 2011
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: April 2017