The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses
Placebo to match basiliximab
Ocular Immunology & Uveitis Foundation
Cambridge, Massachusetts, United States
Tauber Eye Center
Kansas City, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
Southeast Clinical Research Associates
Belmont, North Carolina, United States
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
Time frame: The primary outcome will be assessed at Week 16
Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed
Time frame: These measures will be assessed at Week 16
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University of Texas Medical Branch
Galveston, Texas, United States
Vitreoretinal Consultants
Houston, Texas, United States