Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration
نویسندگان
چکیده
PurposeTo report the 2-year efficacy and safety of abicipar every 8 weeks quarterly (after initial doses) compared with monthly ranibizumab in patients treatment-naïve neovascular age-related macular degeneration (nAMD).DesignTwo multicenter, randomized, phase 3 clinical trials identical protocols (CEDAR SEQUOIA). Analyses used pooled trial data.ParticipantsThe enrolled 1888 (1 eye/patient) active choroidal neovascularization secondary to best-corrected visual acuity (BCVA) 24 73 Early Treatment Diabetic Retinopathy Study letters.MethodsAt enrollment, were assigned study eye treatment 2 mg after doses at baseline 4 (abicipar Q8, n = 630), 12 Q12, 628), or 0.5 (ranibizumab Q4, 630).Main Outcome MeasuresEfficacy measures included stable vision (<15-letter loss BCVA from baseline) change central retinal thickness (CRT). Safety adverse events (AEs).ResultsFor who completed study, was maintained through week 104. At 104, proportion 93.0% (396/426), 89.8% (379/422), 94.4% (470/498); mean +7.8 letters, +6.1 +8.5 CRT ?147 ?m, ?146 ?142 ?m Q8 (14 injections), Q12 (10 Q4 (25 injections) groups, respectively. The overall incidence intraocular inflammation (IOI) AEs 15.4%, 15.3%, 0.3% 52 16.2%, 17.6%, 1.3% 104 respectively.ConclusionsTwo-year results show nAMD. First onset IOI much reduced second year comparable (0.8% 2.3% vs. 1.0%). extended duration effect allows for dosing burden. To (nAMD). Two data. letters. 630). Efficacy (AEs). For Two-year
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ژورنال
عنوان ژورنال: Ophthalmology
سال: 2021
ISSN: ['2468-7162', '2468-7170']
DOI: https://doi.org/10.1016/j.ophtha.2020.11.017