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法西单抗治疗新生血管性年龄相关性黄斑变性:独立视网膜诊所真实世界结局的首次报告。

Faricimab in neovascular AMD: first report of real-world outcomes in an independent retina clinic.

机构信息

The Retina Clinic London, 140 Harley Street, London, W1G 7LB, UK.

UCL Institute of Ophthalmology, 11-43 Bath Street, London, EC1V 9EL, UK.

出版信息

Eye (Lond). 2023 Oct;37(15):3282-3289. doi: 10.1038/s41433-023-02505-z. Epub 2023 Mar 23.

Abstract

PURPOSE

Assess short-term real-world outcomes in neovascular aged-related macular degeneration (nAMD) treated with novel faricimab.

METHODS

Retrospective case series of nine patients with nAMD (11 eyes) treated with faricimab between May and November 2022. Treatment-naïve patients and non-naïve patients underwent logMAR best corrected visual acuity (BCVA), optical coherence tomography (OCT) DRI OCT-1 Triton (Topcon Corp, Tokyo, Japan), ultra-widefield (UWF) and fundus autofluorescence (FAF) (California Optomap, Optos plc, Dunfermline, Scotland, UK). Previous treatment intervals, number of intravitreal injections, sub/intra retinal fluid (SRF/IRF), central retinal thickness (CRT) and presence/changes in pigment epithelial detachments (PEDs) were recorded.

RESULTS

Mean baseline BCVA and CRT values of patients who switched from other agents were 0.612 ± 0.75 logMAR and 256.16 ± 12.98 µm respectively, with a mean 36-day previous treatment interval. The median number of other previous anti-VEGF intravitreal injections was 8. Mean BCVA at one month significantly improved to 0.387 ± 0.54 logMAR, as well as CRT values which decreased to 245.43 ± 15.34 µm. In the 3 naïve patients, mean baseline BVCA and CRT values were 0.33 ± 0.29 and 874.67 ± 510.86 µm, respectively. At one month follow-up, mean BCVA improved to 0.30 ± 0.29 logMAR and mean CRT was 536.04 ± 36.15 µm. Overall, a significant improvement in BCVA of 0.21 ± 41 logMAR and 238.44 ± 114.9 µm was achieved at one month after the first faricimab intravitreal injection. In addition, a complete resolution of SRF was observed in 6 out of 8 eyes (75%) and of IRF in 2 out of 3 eyes (66.67%), respectively. Drusenoid PED morphology changes were observed in all patients and no drug-related adverse events were observed.

CONCLUSION

Real-world outcomes showed improvement in BCVA and anatomic parameters at an early timepoint, demonstrating the efficacy and durability of faricimab in nAMD patients. Larger numbers of patients and longer follow-up are needed to determine whether the loading dose is required in all, what percentage of patients experience an improvement, and whether improvement it is maintained.

摘要

目的

评估新型 faricimab 治疗新生血管性年龄相关性黄斑变性(nAMD)的短期真实世界疗效。

方法

回顾性病例系列研究,纳入 2022 年 5 月至 11 月期间接受 faricimab 治疗的 9 例 nAMD(11 只眼)患者。初治患者和非初治患者接受最佳矫正视力(BCVA)、光学相干断层扫描(OCT)DRI Triton(Topcon 公司,东京,日本)、超广角(UWF)和眼底自发荧光(FAF)(加利福尼亚 Optomap,Optos plc,邓弗姆林,苏格兰,英国)检查。记录先前的治疗间隔、玻璃体内注射次数、视网膜下/内液(SRF/IRF)、中心视网膜厚度(CRT)和色素上皮脱离(PED)的存在/变化。

结果

从其他药物转换过来的患者的基线 BCVA 和 CRT 值分别为 0.612±0.75 logMAR 和 256.16±12.98 µm,平均上次治疗间隔为 36 天。中位数为 8 次其他先前的抗 VEGF 玻璃体内注射。一个月时,平均 BCVA 显著改善至 0.387±0.54 logMAR,CRT 值降低至 245.43±15.34 µm。在 3 例初治患者中,平均基线 BCVA 和 CRT 值分别为 0.33±0.29 和 874.67±510.86 µm。一个月随访时,平均 BCVA 改善至 0.30±0.29 logMAR,平均 CRT 为 536.04±36.15 µm。总的来说,第一次 faricimab 玻璃体内注射后一个月,BCVA 平均提高了 0.21±41 logMAR,CRT 平均降低了 238.44±114.9 µm。此外,6 只眼(75%)的 SRF 完全消退,3 只眼(66.67%)的 IRF 完全消退。所有患者均观察到类脂性 PED 形态变化,未观察到与药物相关的不良事件。

结论

真实世界的结果显示,BCVA 和解剖参数在早期得到改善,表明 faricimab 在 nAMD 患者中的疗效和持久性。需要更多的患者和更长的随访时间来确定是否所有患者都需要负荷剂量,有多少患者的情况得到改善,以及改善是否得到维持。

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