Patwardhan Ashish, Ali Nadir, Law Stacey
Royal Cornwall Hospitals NHS Trust, Treliske, Truro, Cornwall, TR1 3LJ, England.
Eye (Lond). 2025 Mar;39(4):766-770. doi: 10.1038/s41433-024-03487-2. Epub 2024 Nov 21.
To assess the visual outcome of extension to 12-weekly intervals (Q12W) following 4 loading doses of intravitreal Faricimab injections as described in the TENAYA and LUCERENE trials for the management of treatment-naïve neovascular Age-related Macular Degeneration (nAMD).
A retrospective analysis was carried out on all treatment-naïve nAMD patients who started Faricimab intravitreal injections in the period between 1 September 2022 and 31 January 2023. The data collection included best corrected visual acuity (BCVA) at baseline, 12 weeks, 24 weeks and 52 weeks; Central Subfield Thickness (CST) at baseline, 24 weeks and 52 weeks; Number of injections at 52 weeks; treatment intervals at 52 weeks. Descriptive and correlational analysis, independent and Paired-sample T-tests were used to analyse the data.
Sixty-eight eyes completed the one-year of treatment. The mean (SD) age was 79.9 (8.7) years and 61.8% were females. The mean (SD) number of injections at 52 weeks was 6.8 (0.8). The BCVA improved from baseline by a mean (SD) of 7.0 (10.8) letters at 12 weeks (p < 0.001), 7.3 (12.1) letters at 24 weeks (p < 0.001) and 8.2 (13.4) letters at 52 weeks (p < 0.001). The mean (SD) reduction in CST was 114.8 (SD 122.8) microns at 24 weeks (p < 0.001), and 89.4 (121.9) microns at 52 weeks (p < 0.001).
A Q12W approach following 4 loading doses of Faricimab for the treatment of nAMD in real-world achieves excellent visual outcomes comparable to pivotal trial with optimum number of injections in the first year.
评估按照TENAYA和LUCERENE试验中所述,在给予4剂玻璃体内注射法西单抗负荷剂量后,将给药间隔延长至每12周一次(Q12W)对初治新生血管性年龄相关性黄斑变性(nAMD)的视觉效果。
对2022年9月1日至2023年1月31日期间开始接受玻璃体内注射法西单抗治疗的所有初治nAMD患者进行回顾性分析。数据收集包括基线、12周、24周和52周时的最佳矫正视力(BCVA);基线、24周和52周时的中央子场厚度(CST);52周时的注射次数;52周时的治疗间隔。采用描述性和相关性分析、独立样本和配对样本t检验对数据进行分析。
68只眼完成了一年的治疗。平均(标准差)年龄为79.9(8.7)岁,61.8%为女性。52周时的平均(标准差)注射次数为6.8(0.8)次。BCVA在12周时较基线平均(标准差)提高了7.0(10.8)个字母(p<0.001),24周时提高了7.3(12.1)个字母(p<0.001),52周时提高了8.2(13.4)个字母(p<0.001)。CST在24周时平均(标准差)降低了114.8(标准差122.8)微米(p<0.001),52周时降低了89.4(121.9)微米(p<0.001)。
在现实世界中,对nAMD患者给予4剂法西单抗负荷剂量后采用Q12W方案可取得优异的视觉效果,与关键试验相当,且第一年的注射次数最佳。