TENAYA and LUCERNE

作者：Arshad M. Khanani, Aachal Kotecha, Andrew Chang, Shih‐Jen Chen, Youxin Chen, Robyn H. Guymer, Jeffrey S. Heier, Frank Gerhard Holz, Tomohiro Iida, Jane A. Ives, Jennifer I. Lim, Hugh Lin, Stephan Michels, Carlos Quezada-Ruiz, Ursula Margarethe Schmidt-Erfurth, David G. Silverman, Rishi P. Singh, Balakumar Swaminathan, Jeffrey Ryuta Willis, Ramin Tadayoni, Ashkan Michael Abbey, Elmira Abdulaeva, Prema Abraham, Alfredo Adan Civera, Hansjürgen T. Agostini, Arturo Alezzandrini, Virgil Alfaro, Arghavan Almony, Lebriz Altay, Payam Amini, Andrew N. Antoszyk, Etelka Aradi, Luís Arias, Jennifer Arnold, Riaz Hassan Yusuf Asaria, Sergei Astakhov, Yury Sergeevich Astakhov, Carl C. Awh, Chandra Balaratnasingam, Sanjiv Banerjee, Caroline R. Baumal, Matthias Dieter Becker, Rubens Belfort, Galina Bratko, William Z. Bridges, Jamin S. Brown, David M. Brown, Maria V. Budzinskaya, S. Buffet, Stuart C Burgess, Ik Soo Byon, Carlo Cagini, Jorge I. Calzada, Stone Cameron, Peter A. Campochiaro, John S. Carlson, Ângela M. Carneiro, Clement W. N. Chan, Emmanuel Chang, Andrew Chang, Daniel L. Chao, Nauman A Chaudhry, Caroline Chee, Andrew Cheek, Shih‐Jen Chen, San‐Ni Chen, Gemmy Cheung, Saradha Chexal, Mark E. Chittum, David Robert Chow, Abosede Cole, Brian M. Connolly, Pierre Loïc Cornut, Stephen S. Couvillion, Carl J. Danzig, Vesselin Daskalov, Amr L Dessouki, François Devin, Michael L. Dollin, Rosa Dolz, Louise Downey, Richard F. Dreyer, Pravin U. Dugel, David A. Eichenbaum, Bora M. Eldem, Robert E. Engstrom, Joan Josep Escobar, Nicole Eter, David Faber, Naomi S. Falk, Leonard Feiner, Alvaro Fernandez Vega, Philip J. Ferrone, Marta S. Figueroa, Howard F. Fine, Mitchell S. Fineman, Gregory M. Fox, Catherine Français, Pablo Moreno Franco, Samantha Fraser‐Bell, Nicholas Siu Kay Fung, Federico Furno Sola, Richard Peter Gale, Alfredo García‐Layana, Julie Gasperini, Maciej Gawęcki, Faruque D. Ghanchi, Manjot K. Gill, Michel Giunta, David L. Glaser, Michaella Goldstein, Francisco Gomez Ulla, Fumi Gomi, Víctor H. González, J. L. GRAFF, Sunil R. Gupta, Rainer Guthoff, Robyn H. Guymer, Anton Haas, Robert L. Hampton, Katja B. Hatz, Ken Hayashi, Jeffrey S. Heier, Ewa Herba, Vrinda S. Hershberger, Patrick M. Higgins, Nancy M. Holekamp, Shigeru I. Honda, James Griffiths Howard, Allen Y. H. Hu, Stephen Huddleston, Tomohiro Iida, Hiroko Imaizumi, Yasuo Ito, Yasuki Ito, Sujit Itty, Golnaz Javey, Cameron G. Javid, Tatsushi Kaga, Jakub J Kałuzny, Se Woong Kang, Kapil Kapoor, Levent V. Karabas, Tsutomu Kawasaki, Patrick Kelty, Ágnes Kerényi, Arshad M. Khanani, Ramin Khoramnia, Rahul N. Khurana, Kazuhiro Kimura, Kendra Klein-Mascia, Namie Kobayashi, Laurent Kodjikian, Hideki Koizumi, Gregg T. Kokame, Alexey Nikolaevich Kulikov, Henry Kwong, Robert Kwun, Timothy Y. Y. Lai, Chi‐Chun Lai, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Adrian Lavina, Won Ki Lee, Ji Eun Lee, Seong Lee, Jaime Levy, Lucas B. Lindsell, Mimi Liu, Nikolas J. S. London, Andrew John Lotery, David Lozano Rechy, Alan Luckie, David Maberley, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Dennis M. Marcus, Alan R. Margherio, Hélène Massé, Hisashi Matsubara, Raj K. Maturi, Sonia Mehta, Geeta Menon, Jale Menteş, Mark Michels, Yoshinori Mitamura, Paul Mitchell, Quresh Amir Mohamed, Jordi Monés, Rodrigo Montemayor Lobo, Javier Montero, Jeffrey S. Moore, Ryusaburo Mori, Haia Morori-Katz, Rajarshi Mukherjee, Toshinori Murata, Maria Muzyka−Woźniak, Marco Nardi, Niro Narendran, Massimo Nicolò, Jared S. Nielsen, Tetsuya Nishimura, Kousuke Noda, Anna Nowińska, Hideyasu Oh, Matthew P. Ohr, Annabelle Ayame Okada, Piotr Oleksy, Shinji Ono, Şengül Özdek, Banu Turgut Ozturk, Luis Emilio Pablo, Kyu Hyung Park, D. Wilk Parke, Maria Cristina Parravano, Praveen J. Patel, Apurva R. Patel, Sunil S. Patel, Sugat K. Patel, Daniel Pauleikhoff, Ian Pearce, Joel A. Pearlman, Iva Petkova, Dante J. Pieramici, Nadezhda A. Pozdeyeva, Jawad H. Qureshi, Dorota Raczyńska, Juan Ramirez Estudillo, Rajiv Rathod, Hessam Razavi, Carl D. Regillo, Gayatri S. Reilly, Federico Ricci, Ryan Rich, Bożena Romanowska‐Dixon, Irit Rosenblatt, José M. Ruiz‐Moreno, Stefan Sacu, Habiba Saedon, Usman Saeed, Min Sagong, Taiji Sakamoto, Sukhpal S. Sandhu, Laura Sararols, Mario Saravia, Ramin Schadlu, Patricio G. Schlottmann, Tetsuju Sekiryu, András Seres, Figen Şermet, Sumit P. Shah, Rohan M. Shah, Ankur M. Shah, Tom Sheidow, Veeral S. Sheth, Chieko Shiragami, Bartosz L. Sikorski, Rufino Martins da Silva, Lawrence J. Singerman, Robert A. Sisk, Torben Lykke Sørensen, Eric H. Souied, David-J. Spinak, Giovanni Staurenghi, Robert L. Steinmetz, GLENN L. STOLLER, Robert Stoltz, Eric Suan, Iván J. Suñer, Suzanne Yzer, Ramin Tadayoni, Kanji A. Takahashi, Kei Takayama, Alexandre Chater Taleb, James Stephen Talks, Hiroko Terasaki, John F. Thompson, Edit Tóth‐Molnár, Khoi A Tran, Raman Tuli, Eduardo Uchiyama, Attila Vajas, Janneke Van Lith-Verhoeven, Balázs Varsányi, Francesco Viola, Gianni Virgili, Gábor Vogt, Michael Völker, David J. Warrow, Pamela Weber, John A. Wells, Sanjeewa Wickremasinghe, Mark R. Wieland, Geoff A. Williams, Thomas Neil Williams, David T. Wong, King Wong, James S. W. Wong, Ian Chi Kei Wong, Robert Wong, Bogumił Wowra, Charles C. Wykoff, Ayana Yamashita, Kanako Yasuda, Gürsel Yılmaz, Glenn C. Yiu, Ai Yoneda, Young Hee Yoon, Yoreh Barak, Hyeong Gon Yu, Seung Young Yu, Tatiana Vladimirovna Yurieva, Alberto Zambrano, Barbara Zatorska, Carlos Zeolite · 发表于：Ophthalmology · 年份：2024 · DOI：10.1016/j.ophtha.2024.02.014 · 被引用次数：220 · 研究领域：Retinal Diseases and Treatments、Ophthalmology and Visual Impairment Studies、Ocular Diseases and Behçet’s Syndrome

PURPOSE: To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. DESIGN: TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. PARTICIPANTS: Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. METHODS: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. MAIN OUTCOME MEASURES: Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. RESULTS: Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [9...