Ustekinumab for Active Sight-Threatening Uveitis

Sponsor
National Eye Institute (NEI)
Study ID
NCT01647152
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 3, 2012
Status verified
Sep 2014
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

The primary outcome is the number of participants who experience at least a 2-step (or down to grade 0) reduction in inflammation as per the Standardization of Uveitis Nomenclature (SUN) criteria by Week 8.

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