Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Department of Ophthalmology, Kim's Eye Hospital, Seoul, Republic of Korea.
Ophthalmologica. 2023;246(3-4):192-202. doi: 10.1159/000529410. Epub 2023 Jan 31.
The aim of the study was to determine the short-term real-world safety and efficacy of intravitreal brolucizumab injections in Korean patients with neovascular age-related macular degeneration (nAMD).
This multicenter retrospective study involved 294 eyes (treatment naïve 20 eye [6.8%] and nontreatment naïve 274 eyes [93.2%]) of 290 patients from 13 hospitals or retinal centers in South Korea. Patients with nAMD who received brolucizumab injection(s) between April 1 and November 30, 2021, with a follow-up ≥1 month, were included. Primary outcomes were safety, incidence of intraocular inflammation (IOI), and potential risk factors. The secondary outcome was efficacy, i.e., change in best-corrected visual acuity (BCVA) and optical coherence tomography-measured macular thickness and retinal fluid.
The mean age was 71.63 ± 8.66. The follow-up period was 2.38 ± 0.79 months. The mean number of brolucizumab injections during the follow-up was 1.52 ± 0.58. The overall incidence of IOI was 13.9% (n = 41 eyes). Most IOI cases were of anterior uveitis (8.8%, 26 eyes), followed by retinal vasculitis (2.4%, seven eyes) and occlusive retinal vasculitis (0.3%, one eye). Most eyes showed IOI resolution (n = 40, 97.5%) and BCVA restoration (n = 39, 95.1%) with or without corticosteroid treatment during the follow-up. Age, sex, IOI history, or other anti-vascular endothelial growth factor injection histories were not associated with the occurrence of IOI. However, only thin subfoveal choroidal thickness (SFCT) was associated with the occurrence of IOI (odds ratio = 0.995, p = 0.020). BCVA at 1 month improved from baseline (baseline 0.518 ± 0.356 vs. 1 month 0.503 ± 0.383, p = 0.023), but the improvement was not maintained. Anatomical improvement was significant after 3 months.
In Korean patients with nAMD, the incidence of IOI following brolucizumab injections was 13.9%. IOI was well-controlled with or without steroid treatment. Most IOI eyes (95.1%) were restored to the level of vision before. IOI occurrence and occlusive vasculitis was rare. In the short term, brolucizumab injection effectively improved vision at 1 month and dried retinal fluid for 3 months.
本研究旨在确定玻璃体内注射布罗利珠单抗治疗韩国新生血管性年龄相关性黄斑变性（nAMD）患者的短期真实世界安全性和疗效。
这是一项多中心回顾性研究，纳入了来自韩国 13 家医院或视网膜中心的 290 名患者的 294 只眼（治疗初治 20 只眼[6.8%]和非治疗初治 274 只眼[93.2%]）。纳入了 2021 年 4 月 1 日至 11 月 30 日期间接受布罗利珠单抗注射且随访时间≥1 个月的 nAMD 患者。主要结局为安全性、眼内炎症（IOI）发生率和潜在危险因素。次要结局为最佳矫正视力（BCVA）和光学相干断层扫描测量的黄斑厚度和视网膜液变化的疗效。
患者的平均年龄为 71.63±8.66 岁。随访时间为 2.38±0.79 个月。随访期间布罗利珠单抗注射的平均次数为 1.52±0.58。IOI 的总发生率为 13.9%（n=41 只眼）。大多数 IOI 病例为前葡萄膜炎（8.8%，26 只眼），其次为视网膜血管炎（2.4%，7 只眼）和闭塞性视网膜血管炎（0.3%，1 只眼）。大多数眼在随访期间均出现 IOI 缓解（n=40，97.5%）和 BCVA 恢复（n=39，95.1%），无论是否接受皮质类固醇治疗。年龄、性别、IOI 史或其他抗血管内皮生长因子注射史与 IOI 的发生无关。然而，只有薄的中心凹下脉络膜厚度（SFCT）与 IOI 的发生相关（比值比=0.995，p=0.020）。治疗后 1 个月 BCVA 从基线（基线 0.518±0.356 vs. 1 个月 0.503±0.383，p=0.023）提高，但改善未维持。3 个月后解剖学改善明显。
在韩国 nAMD 患者中，布罗利珠单抗注射后 IOI 的发生率为 13.9%。IOI 经皮质类固醇治疗或不治疗后得到很好的控制。大多数 IOI 眼（95.1%）恢复到治疗前的视力水平。IOI 发生和闭塞性血管炎罕见。短期内，布罗利珠单抗注射可有效改善 1 个月时的视力，并在 3 个月时干燥视网膜液。
