Ustekinumab for Active Sight-Threatening Uveitis

Summary

Background: \- Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops, drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type of white blood cells called T-cells often have a role in causing uveitis. In some cases of uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat uveitis. Objectives: \- To see if ustekinumab can be used to treat uveitis. Eligibility: \- Individuals at least 18 years of age who have active uveitis that needs treatment. Design: * Participants will be screened with a physical exam, eye exam, and medical history. Blood and urine samples will be taken. * Participants will have at least eight clinic visits during the 64-week study period. After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks. * Participants will have a ustekinumab injection at the first study visit. They will have additional doses at the second and third visits, and then every 12 weeks until 1 year after the first dose (Week 52). * Treatment will be monitored with frequent blood tests and eye exams. Other standard treatments for uveitis may be given as needed. * There will be a final study visit 3 months after the last injection.

Timeline

Start

2012-07-03

Primary completion

2015-06-30

Completion

2015-06-30

Publications

• Background Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.
• Background Djalilian AR, Nussenblatt RB. Immunosuppression in uveitis. Ophthalmol Clin North Am. 2002 Sep;15(3):395-404, viii. doi: 10.1016/s0896-1549(02)00036-6.
• Background Luger D, Silver PB, Tang J, Cua D, Chen Z, Iwakura Y, Bowman EP, Sgambellone NM, Chan CC, Caspi RR. Either a Th17 or a Th1 effector response can drive autoimmunity: conditions of disease induction affect dominant effector category. J Exp Med. 2008 Apr 14;205(4):799-810. doi: 10.1084/jem.20071258. Epub 2008 Apr 7.

Drugs

Indications