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Efficacy of every 4 monthly and quarterly dosing of faricimab vs ranibizumab in neovascular age-related macular degeneration: The STAIRWAY phase 2 randomized clinical trial

JAMA Ophthalmology Sep 14, 2020

Khanani AM, Patel SS, Ferrone PJ, et al. - In this phase 2 randomized clinical trial, researchers compared extended dosing with faricimab vs monthly ranibizumab in treating patients with neovascular age-related macular degeneration. This 52-week multicenter, active comparator–controlled, parallel-group study was performed including in 76 patients. They randomized the participants to receive intravitreal ranibizumab, 0.5 mg, every 4 weeks or faricimab, 6.0 mg, every 12 or 16 weeks. Initially 4 monthly injections of faricimab were provided to participants in the faricimab arms. At week 24, disease activity was assessed in participants randomized to dosing every 16 weeks using prespecified criteria. In those with no active disease, dosing every 16 weeks was continued through trial end; in participants with disease activity, dosing every 12 weeks was continued. For the monthly ranibizumab, faricimab every-12-weeks, and faricimab every-16-weeks arms, vision gains from baseline were +9.6, +10.1, and +11.4 letters, respectively, at week 52. Findings suggest that faricimab maintains initial vision and anatomic improvements comparable with ranibizumab in neovascular age-related macular degeneration, through simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A. Based on the findings, they support pursuing extended interval dosing with faricimab in phase 3 trials as a potential alternative to more frequently dosed anti–vascular endothelial growth factor therapy.

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