Overview

Ustekinumab for Active Sight-Threatening Uveitis

Status:
Withdrawn
Trial end date:
2015-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Ustekinumab