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Withdrawn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

First listed
Jul 20, 2012
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.

Related Studies