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J. T. Rosenbaum, Representing the LUMINATE Steering Committee; LUVENIQTM (LX211/Voclosporin) as Corticosteroid-Sparing Therapy in Sight-Threatening Non-Infectious Uveitis: Results From Three Prospective, Randomized, Multicenter, Double-Masked, Placebo-Controlled Phase 2/3 Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2021.
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To report efficacy and safety data of LUVENIQTM (LX211/voclosporin) in sight threatening non-infectious uveitis as evaluated by the LUMINATE clinical program.
Three prospective, randomized, multi-center, double-masked, parallel-group, dose-ranging, placebo-controlled studies comprise the LUMINATE clinical program. Study LX211-01, LUMINATE Posterior, evaluated 218 patients with active predominantly posterior disease manifestation with mean change in vitreous haze as the primary endpoint. Study LX211-02, LUMINATE Maintenance, evaluated 232 patients with quiescent disease with the proportion of subjects experiencing disease exacerbation as assessed by vitreous haze, anterior chamber cells or vision loss as primary endpoint. Study LX211-03, LUMINATE Anterior Active, evaluated 108 patients with active predominantly anterior disease manifestation with mean change in anterior chamber cells as the primary endpoint. The LUMINATE studies evaluated three doses of LUVENIQTM (LX211/voclosporin; 0.2mg/kg, 0.4mg/kg, and 0.6mg/kg administered orally twice daily) and placebo in a 2:2:2:1 ratio respectively.
Data analysis for the three protocols will be completed by end of February 2009. A total of 558 subjects in 57 centers in North America, Europe and India were recruited. Median age of subjects at baseline in the LX211-01 study was 41.8 years, in the LX211-02 study 42.8 years, and in the LX211-03 study 36.7 years. Additional baseline characteristics included: mean duration since uveitis diagnosis (LX211-01: 4.3 years; LX211-02: 4.3 years; LX211-03: 4.5 years); systemic steroid dosage [prednisone or equivalent] (LX211-01: 22.6 mg/day; LX211-02: 15.5 mg/day; LX211-03: 19.8 mg/day); visual acuity [ETDRS] (LX211-01: 61.7 letters, LX211-02: 73.3 letters, LX211-03: 69.7 letters); mean vitreous haze (LX211-01: 2.1, LX211-02: 0.5, LX211-03: 0.9); mean anterior chamber cells (LX211-01: 0.6, LX211-02: 0.2, LX211-03: 2.2); and presence of bilateral disease (LX211-01: 86.7%, LX211-02: 89.0%, LX211-03: 74.8%).
The study design and enrollment success will provide data to evaluate the safety, efficacy, and dosing of LUVENIQTM in uveitis patients.
Clinical Trial: :
www.clinicaltrials.gov NCT00404612; NCT0040472; NCT00404885
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