Ohnaka Masayuki, Sakurada Yoichi, Hayashi Atsushi, Kadonosono Kazuaki, Ohno Hitoshi, Mori Ryusaburo, Matsumoto Hidetaka, Nagamori Ippei, Murata Yuki, Maio-Twofoot Tina, Karcher Helene, Takahashi Hidenori
Department of Ophthalmology, Kansai Medical University, Osaka, Japan.
Department of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.
Ophthalmol Ther. 2025 May 28. doi: 10.1007/s40123-025-01159-2.
The aim of this study was to evaluate the real-world outcomes of brolucizumab use in Japanese patients with neovascular age-related macular degeneration (nAMD).
PHEASANT was a retrospective, multicenter, single-arm cohort study. The study included 438 patients, of whom 123 were treatment-naïve and 315 were pre-treated. The primary outcome was retinal fluid (subretinal fluid [SRF] and intraretinal fluid [IRF]) resolution at month 12, with change in visual and retinal anatomy parameters and safety assessed as key secondary outcomes.
At baseline in the treatment-naïve cohort, 10.1% (n = 7/69) of patients were free of retinal fluid, increasing to 62.3% (n = 43/69) at month 12. In the pre-treated cohort, 14.9% (n = 30/201) of patients were free of retinal fluid at baseline, increasing to 43.8% (n = 88/201) at month 12. The median (interquartile range [IQR]) injection interval for pre-treated patients at month 12 was extended by 21 (7.0-35.0) days. The overall intraocular inflammation rate (including the rate of retinal vasculitis/retinal occlusive vasculitis of 0.46% [2/438]) was 8.4% (n = 37/438).
In a real-world clinical setting, brolucizumab was effective at drying the retina in treatment-naïve and pre-treated Japanese nAMD patients and therefore has the potential to reduce the treatment burden by prolonging injection intervals. Safety outcomes support the overall favorable benefit/risk profile of brolucizumab.
NCT06699914.
本研究旨在评估布罗卢izumab在日本新生血管性年龄相关性黄斑变性(nAMD)患者中的真实世界疗效。
雉鸡研究是一项回顾性、多中心、单臂队列研究。该研究纳入了438例患者,其中123例为初治患者,315例为经预处理患者。主要结局是第12个月时视网膜液(视网膜下液[SRF]和视网膜内液[IRF])的消退情况,视觉和视网膜解剖参数的变化以及安全性作为关键次要结局进行评估。
在初治队列的基线时,10.1%(n = 7/69)的患者无视网膜液,在第12个月时增至62.3%(n = 43/69)。在经预处理队列中,14.9%(n = 30/201)的患者在基线时无视网膜液,在第12个月时增至43.8%(n = 88/201)。经预处理患者在第12个月时的中位(四分位间距[IQR])注射间隔延长了21(7.0 - 35.0)天。总体眼内炎症发生率(包括视网膜血管炎/视网膜闭塞性血管炎发生率为0.46%[2/438])为8.4%(n = 37/438)。
在真实世界临床环境中,布罗卢izumab在初治和经预处理的日本nAMD患者中对视网膜脱水有效,因此有可能通过延长注射间隔减轻治疗负担。安全性结局支持布罗卢izumab总体良好的获益/风险状况。
NCT06699914。