Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). Two multicenter, randomized, phase 3 clinical trials with identical protocols...

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Veröffentlicht in:Ophthalmology (Rochester, Minn.) Minn.), 2021-07, Vol.128 (7), p.1027-1038
Hauptverfasser: Khurana, Rahul N., Kunimoto, Derek, Yoon, Young Hee, Wykoff, Charles C., Chang, Andrew, Maturi, Raj K., Agostini, Hansjürgen, Souied, Eric, Chow, David R., Lotery, Andrew J., Ohji, Masahito, Bandello, Francesco, Belfort, Rubens, Li, Xiao-Yan, Jiao, Jenny, Le, Grace, Kim, Kimmie, Schmidt, Werner, Hashad, Yehia
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Sprache:eng
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Zusammenfassung:To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data. The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to age-related macular degeneration and best-corrected visual acuity (BCVA) of 24 to 73 Early Treatment Diabetic Retinopathy Study letters. At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630). Efficacy measures included stable vision (
ISSN:0161-6420
1549-4713
DOI:10.1016/j.ophtha.2020.11.017