Outcomes and measures
choroidal or retinal lesions, haze, uveitis, retinal detachment
ADVERSE EVENTS, UVEITIS, RETINAL DETACHMENT, DILATION, INTRAOCULAR PRESSURE
Trial visits were scheduled at week 2, week 9, week 17, and week 26. Clinical evaluation of uveitis activity was performed by the unmasked treating clinician with the use of slit-lamp microscopy and ophthalmoscopy with pupillary dilation. Inactive uveitis was defined as eyes with an anterior chamber cell grade ≤0.5+, a vitreous haze grade ≤0.5+, and no active inflammatory choroidal or retinal lesions. Examinations of best-corrected visual acuity (BCVA), intraocular pressure, visual field (central 24-degree tested with a 54-point grid), fundus photography, OCT, and FFA were carried out by masked certified personnel who were unaware of the treatment assignment with a standardized procedure (Supplementary Table Secondary outcomes included the proportion of patients achieving an improvement in ETDRS score by 15 letters or greater at week 26, the proportion of patients achieving inactive uveitis in both eyes at week 26, the changes from baseline to week 26 in visual field indices, including visual field index, mean deviation, and pattern standard deviation, the resolution of retinal detachment detected by OCT at week 26, the change from baseline in central macular thickness on OCT at week 26, the proportion of patients initially assigned to cyclosporine therapy who received step-up treatment, and the changes from baseline in EQ-5D score and VFQ-25 composite score at week 26. Safety outcomes included frequency, severity, and relatedness of adverse events through week 26, adjudicated by independent safety monitors.