This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters
Time frame: Baseline to 24 weeks
Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks
Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment \& baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome
Time frame: Baseline to 24 weeks
Mean Change in Best Corrected Visual Acuity From Baseline
The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.
Time frame: Baseline to 24 weeks
Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks
The changes in steps (0, 1, or \>= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (\<1+ anterior chamber cell grade and \<1+ vitreous haze) for at least 2 weeks
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Placebo s.c weekly for 3 weeks then every 2 weeks
Sall Research Medical Center
Artesia, California, United States
Novartis Investigative Site
Artesia, California, United States
Novartis Investigative Site
Beverly Hills, California, United States
Retina-Vitreous Assoc. Medical Group
Beverly Hills, California, United States
Emory University
Atlanta, Georgia, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
University of Louisville Opthamology
Louisville, Kentucky, United States
Novartis Investigative Site
Baltimore, Maryland, United States
The Wilmer Eye Institute
Baltimore, Maryland, United States
...and 84 more locations
Time frame: Baseline to 24 weeks