Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy

作者：Won Ki Lee, Tien Yin Wong, Shih Jen Chen, Xiaodong Sun, Chui Ming Gemmy Cheung, Rufino Silva, Federico Ricci, Xin Zhang, Tobias Machewitz, Andrea Schulze, Ursula Schmidt-Ott, Min Zhao, Zoran Hasanbasic, Sergio Leal, Tomohira Iida, PULSAR Study Investigators, Patricio G. Schlottmann, Tamara Zompa, Arturo Alezzandrini, Andrew Chang, Jennifer Arnold, Samantha Fraser‐Bell, Alan Luckie, Nitin Verma, Yosuf El‐Shabrawi, Peter Reinelt, Oliver Findl, Anton Haas, Matthias Bolz, Veselin Daskalov, D. Mitova, H. Blagoeva, Hristina Grupcheva, Aleksandar Oscar, Iva Petkova, Andrei Andreev, Tom Sheidow, Keyvan Koushan, Louis-Pierre Gauvin, Xiaodong Sun, Mingchang 明昌 Zhang 张, Ke 珂 Fan 范, Xueyi 雪艺 Chen 陈, Mei Han, Hong Dai, Jun 骏 Xiao 肖, Wenhui 文慧 Yang杨, Xufang 旭芳 Sun 孙, Xiaoling 晓玲 Liu 刘, Shaoping 少平 Ha 哈, Jing Lin 静琳 Zhang 张, Qiong 琼 Zhou 周, Xuguang 旭光 Sun 孙, Xiaofeng晓 峰 Li李, Yalin 雅琳 He 贺, Ling 玲 Xu 徐, Miaoqin 苗琴 Wu 吴, Jianping 剑萍 Tong 童, Jian 健 Guo 郭, Yi 一 Wang 王, Wenbin Wei, Mingwei 明威 Zhao 赵, Xiaorong Li, Cheng 澄 Pei 裴, Liming 黎明 Tao 陶, Suyan 甦雁 Li 李, Lifei 莉菲 Wang 王, Yanlong Bi, Xu 旭 Qiu 邱, Qian 骞 Ren 任, Jan Ernest, Jan Němčanský, Jan Studnička, Miroslav Veith, Jan Hamouz, Martin Choleva, H Fidranská, Katrin Hannus, Kuldar Kaljurand, Eric Souied, Ramin Tadayoni, François Devin, Hessam Razavi, Marina Ramazashvili, George Chichua, Mikheil Omiadze, Jakob Jikia, György Bátor, Ágnes Kerényi, András Seres, András Papp, Edit Tóth‐Molnár, Attila Vajas, Balázs Varsányi, Gábor Vogt, Tibor Milibák, Norbert Czumbel, Elad Moisseiev, Eva Platner, Shiri Shulman, Nurit Mathalone, Yoreh Barak, Haia Morori-Kats, Tareq Jaouni, Francesco Bandello, Federico Ricci, Monica Varano, Carlo Cagini, Enrico Peiretti, Angelo Maria Minnella, Giovanni Staurenghi, Akiko 明子 Miki 三木, Hideyasu Oh, Ken 研 Hayashi 林, Tatsuya 竜也 Fujisaki 藤﨑, Tsutomu Yasukawa, Tetsuju Sekiryu, Tetsuo 哲生 Ueda 上田, Yuki 祐基 Morizane 森實, Hideki 英貴 Koizumi 古泉, Shigeo 茂生 Yoshida 吉田, Hisashi Matsubara, Takeshi 剛 Iwase 岩瀬, Yasuo Ito, Jun 潤 Takeuchi 武内, Kanji 寛二 Takahashi 髙橋, Yosuke 陽介 Harada 原田, Kazuhiro Kimura, Toru 徹 Noda 野田, Daisuke 大輔 Takemoto 竹本, Kazuhiko 和彦 Dannoue 檀之上, Yoshinori 佳典 Mitamura 三田村, Kenichi 賢一 Kimoto 木許, Genichiro Kishino, Ryo 亮 Obata 小畑, Yoichi Sakurada, Toshinori Murata, Tetsuya哲哉 Nishimura西村, Ai 愛 Yoneda 米田, Hiroshi 洋 Sasaki 佐々木, Hiroshi Otake, Shunji Kusaka, Kyoko 京子 Fujita 藤田, Kiyoshi 清 Ishii 石井, Yasuhiro Ikeda, Yoko 洋子 Ozawa 小澤, Hajime Shinoda, Kimimasa Muranaka, Ken Ogino, Kiyoshi Suzuma, Toshio Okanouchi, Hideo 英雄 Akiyama 秋山, Namie 奈美江 Kobayashi 小林, Tomohiro 知弘 Iida 飯田, Katsuhiro Nishi, Hiroki 宏樹 Tanaka 田中, Hiroko Imaizumi, Jiro Kogo, Kanako Yasuda, Tomoko 友子 Noda 野田, Iksoo 익수 Byon 변, Young Hee Yoon, Se Woong Kang, Eun Kyoung 경 Lee 이, Se Joon 세준 Woo 우, Mihyun Choi, Woong 웅 Kim Hyun, Indars Lacis, Guna Laganovska, Kristīne Baumane, Jūratė Vilma Balčiūnienė, Andrius Cimbalas, Jurgita Kazlauskaite, Rufino Silva, Carlos Marques‐Neves, Miguel Lume, Luís F.O. Silva, João Figueira, M V Budzinskaya, Boris Malyugin, Miroslav Stamenković, Dijana Risimić, Siniša Babović, Caroline Chee, Chui Ming Gemmy Cheung, Marek Kacerik, Petr Kolář, Blandína Lipková, Gabriela Pavlovičová, Maria Hurcikova, Laura Sararols Ramsay, José M. Ruiz‐Moreno, José I. Vela, Alfredo Manuel Adán Civera, Miguel González Andrades, Luís E. Pablo, Enrique Cervera Taulet, María Isabel Fernández Rodríguez, Patricia Udaondo Mirete, Matthias Becker, Aude Ambresin, Justus G. Garweg, Wei-Chi 為吉 Wu 吳, A. Korol, І. М. Bezkorovayna, Tetiana Shyshkina, Viacheslav Povkh, Nauman Chaudhry, Jeffrey S. Heier, John A. Wells, Michael Singer, Philip J. Ferrone, Glenn Stoller, Kenneth Graham, H. Matthew Wheatley, Patrick Williams, Michael Lee, Eric Suan, Judy Liu, Patrick Higgins, David Eichenbaum, Ghassan Ghorayeb, Robert S. Wirthlin, Ramin Schadlu, Benjamin J. Thomas, Payam Amini, Calvin E. Mein, Sunir J. Garg, David Brown, Steven Charles, Charles C. Wykoff, Robert A. Mittra, Nikolas London, Veeral Sheth, Matthew A. Cunningham, N A Farber, M. Brandon Parrott, Eduardo Uchiyama, Edward F. Cherney, John D. Pitcher, Prema Abraham, Erik Kruger, James D. Palmer, D. Virgil Alfaro, Wilfredo Lara, Sugat Patel, Sarah P. Read, Brian Kim, Aaron Weinberg, Vrinda Hershberger, David Almeida, James W. Dooner, John S. Carlson, Mihai Mititelu, Rajiv Shah, William D. Freeman, Sunil Gupta, Ashkan Pirouz, Robert Feldman, Scott M. McClintic, Kapil M. Sampat, Ramin Sarrafizadeh, Jared S. Nielsen, Carl J. Danzig · 发表于：JAMA Ophthalmology · 年份：2025 · DOI：10.1001/jamaophthalmol.2025.5098 · 被引用次数：4 · 研究领域：Ocular Diseases and Behçet’s Syndrome、Retinal Diseases and Treatments、Retinal and Optic Conditions

Importance: In the Study of the Effects of High-Dose Aflibercept Injected Into the Eye of Patients With an Age-Related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye (PULSAR) phase 3 randomized clinical trial, treatment with aflibercept, 8 mg, demonstrated noninferior (4-letter margin) best-corrected visual acuity (BCVA) gains vs aflibercept, 2 mg, in participants with neovascular age-related macular degeneration (nAMD). This post hoc subgroup analysis evaluated clinical outcomes in participants with polypoidal choroidal vasculopathy (PCV). Objective: To compare the efficacy and safety of aflibercept, 8 mg vs 2 mg, monotherapy among participants with PCV in the PULSAR trial. Design, Setting, and Participants: This was a post hoc subgroup analysis of the PULSAR randomized clinical trial. The setting included hospitals and clinics in 12 countries where indocyanine green angiography (ICGA) was performed to identify PCV. Included were a subgroup of adults with nAMD enrolled in the PULSAR trial with ICGA-confirmed PCV. Study data were analyzed from August 2020 to July 2022. Interventions: Participants were randomly assigned 1:1:1 to aflibercept, 8 mg, every 12 weeks or 16 weeks, or aflibercept, 2 mg, every 8 weeks, each after 3 initial monthly doses. From week 16, dosing intervals in the treatment arms receiving 8 mg every 12 weeks and every 16 weeks were shortened if predefined disease activity criteria were met at prespecified ...