Sim Sing Yue, Chalkiadaki Evangelia, Koutsocheras Georgios, Nicholson Luke, Sivaprasad Sobha, Patel Praveen J, Selvam Senthil, Pal Bishwanath, Keane Pearse A, Bhatia Bhairavi, Hamilton Robin
National Institute for Health and Care Research, Biomedical Research Centre at Moorfields Eye Hospital National Health Service Foundation Trust and University College London Institute of Ophthalmology, London, United Kingdom.
National Institute for Health and Care Research, Biomedical Research Centre at Moorfields Eye Hospital National Health Service Foundation Trust and University College London Institute of Ophthalmology, London, United Kingdom.
Ophthalmol Retina. 2025 Jan;9(1):22-30. doi: 10.1016/j.oret.2024.07.020. Epub 2024 Jul 30.
To report 1-year anatomic and functional real-world outcomes of patients with treatment-intensive neovascular age-related macular degeneration (nAMD) switched to faricimab.
Retrospective multicenter cohort study.
Consecutive nAMD patients on 4-weekly treatment interval with either ranibizumab or aflibercept 2 mg in the last 3 visits within a treat-and-extend protocol (high treatment burden) before switch to faricimab at Moorfields Eye Hospital between September 5, 2022 and December 5, 2022.
Patients with nAMD switched to faricimab were identified from electronic medical records and those who met criteria of high treatment burden were included. Data collected included preswitch and postswitch visual acuity (VA), treatment intervals, baseline macular morphology, central subfield thickness (CST), macular fluid status, and adverse events.
Visual acuity, CST, presence of intraretinal fluid, subretinal fluid, and injection intervals over 1 year after switch to faricimab.
A total of 130 of 286 (45.5%) eyes met inclusion criteria of being switched due to high treatment burden and 117 were included in analysis. Before switch, these eyes received mean total number of injections of 33.4 ± 19.6 over a mean of 51.3 ± 34.9 months. Mean number of injections in 12 months preceding switch was 10.1 ± 1.6 and mean interval of the preceding 3 injections was 4.2 ± 0.3 weeks. Mean VA, CST, and percentage of patients with dry macula before switch were 66.0 ± 11.9 ETDRS letters, 259.6 ± 76.0 μm and 18.3% respectively. After switch, there was no statistical difference in mean VA throughout follow-up period. Mean CST statistically significantly reduced after the third faricimab injection and at 12 months by 20.0 μm (P = 0.035) and 22.1 μm (P = 0.041) respectively. Mean treatment intervals increased to 6.9 ± 2.3 weeks (P < 0.005) at 12 months with 42.9% and 11.4% of patients being on ≥8-weekly and ≥12-weekly treatment intervals, respectively.
At 12 months, nAMD patients with previous record of high treatment burden when switched to faricimab maintained VAs and improved anatomic outcomes on extended treatment intervals. Physician bias is inherent in these types of observational studies so a prospective, randomized, controlled trial is recommended to validate these findings.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
报告转换为法西单抗治疗的强化治疗的新生血管性年龄相关性黄斑变性（nAMD）患者的1年解剖学和功能实际疗效。
回顾性多中心队列研究。
2022年9月5日至2022年12月5日期间在穆尔菲尔兹眼科医院，按照治疗并延长方案（高治疗负担），在过去3次就诊中每4周接受一次雷珠单抗或阿柏西普2mg治疗的连续性nAMD患者，之后转换为法西单抗治疗。
从电子病历中识别出转换为法西单抗治疗的nAMD患者，纳入符合高治疗负担标准的患者。收集的数据包括转换治疗前和转换治疗后的视力（VA）、治疗间隔、基线黄斑形态、中心子野厚度（CST）、黄斑区液体积聚情况和不良事件。
转换为法西单抗治疗后1年内的视力、CST、视网膜内液、视网膜下液的存在情况以及注射间隔。
286只眼中共有130只（45.5%）因高治疗负担符合转换治疗的纳入标准，其中117只眼纳入分析。转换治疗前，这些眼在平均51.3±34.9个月内平均接受了33.4±19.6次注射。转换治疗前12个月的平均注射次数为10.1±1.6次，前3次注射的平均间隔为4.2±0.3周。转换治疗前的平均视力、CST以及干性黄斑患者的百分比分别为66.0±11.9个ETDRS字母、259.6±76.0μm和18.3%。转换治疗后，整个随访期间的平均视力无统计学差异。第三次注射法西单抗后以及12个月时，平均CST分别显著降低了20.0μm（P = 0.035）和22.1μm（P = 0.041）。12个月时平均治疗间隔增加到6.9±2.3周（P < 0.005），分别有42.9%和11.4%的患者治疗间隔≥8周和≥12周。
在12个月时，既往有高治疗负担记录的nAMD患者转换为法西单抗治疗后，视力得以维持，延长治疗间隔时解剖学疗效得到改善。这类观察性研究存在医生偏倚，因此建议进行前瞻性、随机、对照试验以验证这些发现。
在本文末尾的脚注和披露中可能会发现专有或商业披露信息。
