TY - JOUR
T1 - Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration
T2 - 52-Week Results of Phase 3 Randomized Controlled Study
AU - CEDAR and SEQUOIA Study Groups
AU - Kunimoto, Derek
AU - Yoon, Young Hee
AU - Wykoff, Charles C.
AU - Chang, Andrew
AU - Khurana, Rahul N.
AU - Maturi, Raj K.
AU - Agostini, Hansjürgen
AU - Souied, Eric
AU - Chow, David R.
AU - Lotery, Andrew J.
AU - Ohji, Masahito
AU - Bandello, Francesco
AU - Belfort, Rubens
AU - Li, Xiao Yan
AU - Jiao, Jenny
AU - Le, Grace
AU - Schmidt, Werner
AU - Hashad, Yehia
N1 - Funding Information:
Financial Disclosure(s): The author(s) have made the following disclosure(s): D.K.: Consultant ? Allegro, Allergan, Genentech, GrayBug, Novartis, VisionCare; Research funding ? Allergan, Genentech, GrayBug.Y.H.Y.: Consultant ? Alcon, Allergan, Bayer, Boeringer Ingelheim, Roche; Research grants ? Allergan, Bayer, Roche.C.C.W.: Consultant ? Adverum, Aerpio, Alimera Sciences, Allegro, Allergan, Alnylam, Apellis, Bayer, Clearside Biomedical, DORC, EyePoint, Genentech/Roche, Kodiak, Notal Vision, Novartis, ONL Therapeutics, PolyPhotonix, Recens Medical, Regeneron, Regenxbio, Santen; Research support ? Adverum, Aerpio, Allergan, Apellis, Clearside Biomedical, EyePoint, Genentech/Roche, Neurotech, Novartis, Opthea, Regeneron, Regenxbio, Samsung, Santen; Speaker fees ? Regeneron.
Publisher Copyright:
© 2020
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/10
Y1 - 2020/10
N2 - Purpose: To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD). Design: Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. Participants: Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24–73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. Methods: Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). Main Outcome Measures: The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs). Results: The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was −144, −145, and −144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. Conclusions: Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.
AB - Purpose: To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD). Design: Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. Participants: Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24–73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. Methods: Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). Main Outcome Measures: The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs). Results: The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was −144, −145, and −144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. Conclusions: Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.
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U2 - 10.1016/j.ophtha.2020.03.035
DO - 10.1016/j.ophtha.2020.03.035
M3 - Article
C2 - 32471729
AN - SCOPUS:85085337937
VL - 127
SP - 1331
EP - 1344
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 10
ER -