Clinical Trial: Sirolimus as Therapeutic Approach to Uveitis
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase 1, Open-label, Randomized Clinical Study to Assess the Safety, Tolerability and Bioactivity of Intravitreal and Subconjunctival Injection of Sirolimus in Patients With Non-infectious Uveitis
Brief Summary: The purpose of this study is to find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to avoid the potential complications of systemic use of the drug. In this study, the investigators will administer sirolimus either around (subconjunctival injection) or inside the eye (intravitreal injection). 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 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 associated with a slightly increased risk of cancer. Fo
Sponsor: Johns Hopkins University
Current Primary Outcome:
- Frequency of uveitis attacks- assessed by vitreous haze, vitreous cells, and anterior chamber cells [ Time Frame: 6 months ]
- Safety and tolerability of Intravitreal and subconjunctival injections of sirolimus assessed by the frequency and severity of adverse events and serious adverse events that are deemed to be related to sirolimus [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change from baseline VA by ETDRS [ Time Frame: 6 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Johns Hopkins University
Dates:
Date Received: April 30, 2009
Date Started: July 2009
Date Completion: February 2013
Last Updated: May 25, 2010
Last Verified: May 2010
