Scopus
YÖKSİS Eşleşti
Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials
The Lancet · Şubat 2022
YÖKSİS Kayıtları
Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials
The Lancet · 2022 SCI-Expanded
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Makale Bilgileri
DergiThe Lancet
Yayın TarihiŞubat 2022
Cilt / Sayfa399 · 729-740
Scopus ID2-s2.0-85124671320
Özet
Background: Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD). Methods: TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300). Findings: Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [−1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [–1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]). Interpretation: Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD. Funding: F Hoffmann-La Roche.
Yazarlar (98)
1
Jeffrey S. Heier
2
Arshad M. Khanani
ORCID: 0000-0001-8928-5599
3
Carlos Quezada Ruiz
4
Karen Basu
5
Philip Ferrone
6
Christopher Brittain
7
Marta Figueroa
8
Hugh Lin
9
Frank G. Holz
10
Vaibhavi Patel
11
Timothy Y.Y. Lai
12
David Silverman
13
Carl Regillo
14
Balakumar Swaminathan
15
Francesco Viola
16
Chui Ming Gemmy Cheung
17
Tien Y. Wong
18
Ashkan Abbey
19
Elmira Abdulaeva
20
Prema Abraham
21
Alfredo Adan Civera
22
Hansjurgen Agostini
23
Arturo Alezzandrini
24
Virgil Alfaro
25
Arghavan Almony
26
Lebriz Altay
27
Payam Amini
28
Andrew Antoszyk
29
Etelka Aradi
30
Luis Arias
31
Jennifer Arnold
32
Riaz Asaria
33
Sergei Astakhov
34
Yuri S. Astakhov
35
Carl C. Awh
36
Chandra Balaratnasingam
37
Sanjiv Banerjee
38
Caroline R. Baumal
39
Matthias Becker
40
Rubens Belfort
41
Galina Bratko
42
William Z. Bridges
43
Jamin Brown
44
David M. Brown
45
Maria Budzinskaya
46
Sylvia Buffet
47
Stuart Burgess
48
Iksoo Byon
49
Carlo Cagini
50
Jorge Calzada
51
Stone Cameron
52
Peter Campochiaro
53
John Carlson
54
Angela Carneiro
55
Clement Chan
56
Emmanuel Chang
57
Andrew Chang
58
Daniel Chao
59
Nauman Chaudhry
60
Caroline Chee
61
Andrew Cheek
62
Shih Jen Chen
63
San Ni Chen
64
Saradha Chexal
65
Mark Chittum
66
David Chow
67
Abosede Cole
68
Brian Connolly
69
Pierre Loic Cornut
70
Stephen Couvillion
71
Carl Danzig
72
Vesselin Daskalov
73
Amr Dessouki
74
Francois Devin
75
Michael Dollin
76
Rosa Dolz
77
Louise Downey
78
Richard Dreyer
79
Pravin Dugel
80
David Eichenbaum
81
Bora Eldem
82
Robert Engstrom
83
Joan Josep Escobar
84
Nicole Eter
85
David W. Faber
86
Naomi Falk
87
Leonard Feiner
88
Leonard Feiner
89
Howard Fine
90
Mitchell Fineman
91
Gregory M. Fox
92
Catherine Francais
93
Pablo Franco
94
Samantha Fraser-Bell
95
Samantha Fraser-Bell
96
Nicholas Fung
97
Federico Furno Sola
98
Alfredo Garcia-Layana
Kurumlar
Chinese University of Hong Kong
Hong Kong Hong Kong
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan Italy
Genentech, Inc
San Francisco United States
Hoffmann-La Roche Ltd
Mississauga Canada
Hospital Universitario Ramón y Cajal
Madrid Spain
National University of Singapore
Singapore City Singapore
Ophthalmic Consultants of Boston
Boston United States
Roche Products (Ireland)
Dublin Ireland
Roche Products Limited UK
Welwyn Garden City United Kingdom
San Pedro Garza Garcia
Nuevo Leon Mexico
Sierra Eye Associates
Reno United States
Thomas Jefferson University
Philadelphia United States
Università degli Studi di Milano
Milan Italy
Universität Bonn
Bonn Germany
University of Nevada, Reno School of Medicine
Reno United States
Vitreoretinal Consultants of New York
Great Neck United States
Metrikler
279
Atıf
98
Yazar