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Uveitis is an inflammation of the eye that can cause vision loss. It is treated with medications and sometimes surgery. However, in many people, treatment does not always prevent loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other inflammatory diseases. Therefore, it might be helpful in treatment of uveitis.
To see if ustekinumab is safe and can help people with uveitis.
People ages 18 and older with uveitis
Participants will be screened with:
Medical and eye disease history
Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures
are taken of the inside of the eye.
Blood and urine tests
Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include:
Medical and eye disease history
Physical and eye exams
Blood and urine tests
Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is
injected into the tube. The dye travels through the veins up to the blood vessels in the eyes. A
camera takes pictures of the dye as it flows through the blood vessels in the eyes.
Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper
arm, leg, or abdomen.
Participants will have their uveitis monitored and receive standard uveitis care during the study.
Objective: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects and many patients continue to experience disease flare-ups. Ustekinumab is a human IL-12 and -23 antagonist. The involvement of IL-12 and IL-23 in the pathophysiology of uveitis and other autoimmune diseases known to be associated with uveitis suggests that ustekinumab could be a potential treatment for uveitis. The study objective is to investigate the safety, tolerability and potential efficacy of subcutaneous injections of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis.
Study Population: Five participants with active intermediate uveitis, posterior uveitis or panuveitis who meet the inclusion criteria will be initially enrolled. Up to seven participants may be enrolled, as up to two participants may be accrued to account for participants who withdraw from the study prior to Week 16.
Design: This is a prospective, non-randomized, uncontrolled, single-center pilot study to evaluate subcutaneous injections of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis. Participants will receive a 90 mg subcutaneous injection of ustekinumab at baseline and a second and third injection at Week 4 and 8 for a total of 3 injections. Participants will continue in the study for a total of 28 weeks and will be able to receive standard of care after the first 16 weeks.
Outcome Measures: The primary outcome is the number of participants who experience treatment response by Week 16. Secondary outcomes include changes in visual acuity, the number of participants who experience a recurrence, the number of days to recurrence, presence or extent of macular edema, the amount of retino-vascular leakage, changes in retinal thickening, the length of time to quiescence and the ability to taper concomitant immunosuppressive medications. Safety outcomes include the number and severity of systemic and ocular toxicities and adverse events, the proportion of participants who experience vision loss of greater than or equal to 15 letters as measured by Electronic Visual Acuity (EVA) and the number of participants who experience a substantial rise in elevated intraocular pressure (IOP).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
National Institutes of Health Clinical Center
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2016-09-22T21:08:21-0400
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