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玻璃体内注射法西单抗治疗新生血管性年龄相关性黄斑变性的6个月结局及其与临床发现的关系:来自J-CREST的多中心队列研究

6-month outcomes of intravitreal faricimab injection for neovascular age-related macular degeneration and their relationships with clinical findings: a multicentre cohort study from the J-CREST.

作者信息

Yanai Ryoji, Murao Fumiko, Miki Akiko, Terasaki Hiroto, Chujo Shinichiro, Sakaeda Yukinori, Seki Kyosuke, Ishigouoka Gaku, Iwase Takeshi, Ohara Hiromi, Tsujinaka Hiroki, Fukuyama Hisashi, Abe Yuki, Nishi Yuki, Kinoshita Takamasa, Kondo Mineo, Sakamoto Taiji, Mitamura Yoshinori

机构信息

Department of Ophthalmology, Tokushima University, Tokushima, Japan.

Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine, Kobe, Japan.

出版信息

BMJ Open Ophthalmol. 2025 Sep 25;10(1):e002415. doi: 10.1136/bmjophth-2025-002415.

Abstract

BACKGROUND/AIMS: This study aimed to investigate the outcomes of intravitreal faricimab (IVF) injection for neovascular age-related macular degeneration (nAMD) and their relationships with clinical findings.

METHODS

At 14 sites, we retrospectively examined the 6-month treatment outcomes of 186 eyes that underwent IVF for treatment-naïve nAMD or nAMD previously treated except for >3 months before the baseline.

RESULTS

Visual acuity and central retinal thickness (CRT) significantly improved at 1, 3 and 6 months after treatment (p<0.001, respectively). At 3 or 6 months, 151 eyes (81.2%) exhibited dry macula. The dry macula rate in the treatment-naïve group (85.7%) was significantly higher than the previously treated group (71.7%, p=0.022). Eyes with pretreatment submacular haemorrhage (SMH) had a significantly higher rate of dry macula (93.9%) than those without (78.4%, p=0.048). Eyes with pretreatment subretinal fluid had good final visual acuity, but poor visual acuity was observed in those with intraretinal fluid (IRF), subretinal hyper-reflective material (SHRM), SMH or hard exudates. However, a similar tendency was also observed at baseline. CRT improvement was good in the eyes with pretreatment IRF, pigment epithelial detachment, SHRM and SMH, although these eyes had higher CRT at the baseline.

CONCLUSION

IVF treatment for nAMD was associated with improvements in visual acuity and CRT over 6 months. Eyes presenting with SMH showed a higher rate of achieving a dry macula. This result indicates that faricimab may be useful in treating patients with nAMD and SMH. Given the retrospective, non-randomised design, however, these findings should be interpreted cautiously and viewed as hypothesis-generating rather than definitive.

摘要

背景/目的:本研究旨在探讨玻璃体内注射法西单抗(IVF)治疗新生血管性年龄相关性黄斑变性(nAMD)的疗效及其与临床特征的关系。

方法

在14个研究地点,我们回顾性分析了186只接受IVF治疗的初治nAMD或基线前超过3个月未接受治疗的nAMD患者的6个月治疗结果。

结果

治疗后1、3和6个月时,视力和中心视网膜厚度(CRT)均显著改善(p均<0.001)。在3或6个月时,151只眼(81.2%)出现黄斑干性改变。初治组的黄斑干性改变率(85.7%)显著高于既往治疗组(71.7%,p=0.022)。治疗前有黄斑下出血(SMH)的眼,黄斑干性改变率(93.9%)显著高于无SMH的眼(78.4%,p=0.048)。治疗前有视网膜下液的眼最终视力较好,但有视网膜内液(IRF)、视网膜下高反射物质(SHRM)、SMH或硬性渗出的眼视力较差。然而,在基线时也观察到类似趋势。尽管治疗前有IRF、色素上皮脱离、SHRM和SMH的眼基线时CRT较高,但这些眼的CRT改善情况良好。

结论

IVF治疗nAMD在6个月内可改善视力和CRT。出现SMH的眼黄斑干性改变率较高。这一结果表明,法西单抗可能对治疗nAMD合并SMH的患者有用。然而,鉴于本研究为回顾性、非随机设计,这些发现应谨慎解读,视为产生假设而非确定性结论。

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