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新血管性年龄相关性黄斑变性中接受至多3次法西单抗注射的初治和既往治疗患者的真实世界数据。

Real-World-Data of Treatment-Naïve and Previously Treated Patients Receiving Up to 3 Injections of Faricimab in Neovascular Age-Related Macular Degeneration.

作者信息

Kunzmann Berenike Cornelia, Schweig Alexandra Stefanie, Bartz-Schmidt Karl Ulrich, Sobolewska Bianka

机构信息

University Eye Hospital, Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany.

出版信息

Clin Ophthalmol. 2024 Dec 28;18:4029-4039. doi: 10.2147/OPTH.S482948. eCollection 2024.

Abstract

PURPOSE

To evaluate visual and anatomical outcome of consecutive patients who received intravitreal injections (IVI) of faricimab for the treatment of neovascular age-related macular degeneration (nAMD).

PATIENTS AND METHODS

A retrospective study of patients treated for nAMD with one to three IVIs of faricimab from October 2022 to January 2024. Demographic data, treatment history, best corrected visual acuity (BCVA), anatomic parameters, and adverse events (AEs) were collected.

RESULTS

After one IVI of faricimab, previously treated (n=160) eyes with a mean of 33.51 IVIs and treatment-naïve (n=10) eyes showed a mean BCVA gain of +0.59±0.52 letters (p=0.364) and +5.00±6.50 letters (p=0.461), respectively, and a mean central subfield thickness (CST) reduction of -27.65±5.33 µm (p<0.001) and -94.10±39.74 μm (p=0.042), respectively. In treatment-refractory eyes after switching from aflibercept (n=108), mean BCVA increased by +0.42±0.66 (p=0.745) and the mean CST improved by -21.98±6.04 (p<0.001). After three IVIs of faricimab previously treated (n=106) and treatment-naïve (n=5) eyes showed a mean BCVA increase of +1.57±0.88 letters (p=0.051) versus +12.50±8.14 letters (p=0.185), and a mean CST reduction of -25.51±5.82 µm (p<0.001) versus -82.60±36.20 µm from baseline, respectively. In treatment-refractory eyes after switching from aflibercept (n=79), mean BCVA improved by +2.15±1.08 letters (p=0.029) and mean CST decreased by -27.46±7.04 µm (p<0.001). Mean pigment epithelial detachment (PED) was also significantly reduced even between the first and the third faricimab injection in previously treated eyes (p=0.03). The proportion of eyes with intraretinal fluid and subretinal fluid improved significantly in all eyes and treatment-refractory eyes after switching from aflibercept. Ocular AEs were reported in three out of 170 eyes, and one patient had two stroke events during faricimab therapy.

CONCLUSION

Three IVIs of faricimab have the potential to improve visual acuity and anatomical parameters even in treatment-refractory nAMD eyes with a mean dosing interval of more than 6 weeks.

摘要

目的

评估连续接受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(nAMD)患者的视力和解剖学结局。

患者与方法

对2022年10月至2024年1月期间接受1至3次玻璃体内注射法西单抗治疗nAMD的患者进行回顾性研究。收集人口统计学数据、治疗史、最佳矫正视力(BCVA)、解剖学参数和不良事件(AE)。

结果

在接受一次玻璃体内注射法西单抗后,既往接受过治疗的(n = 160)眼平均接受过33.51次注射,初治眼(n = 10)的平均BCVA分别提高了+0.59±0.52字母(p = 0.364)和+5.00±6.50字母(p = 0.461),平均中心子野厚度(CST)分别降低了-27.65±5.33 µm(p < 0.001)和-94.10±39.74 µm(p = 0.042)。从阿柏西普转换治疗的难治性眼(n = 108)中,平均BCVA提高了+0.42±0.66(p = 0.745),平均CST改善了-21.98±6.04(p < 0.001)。在接受三次玻璃体内注射法西单抗后,既往接受过治疗的(n = 106)眼和初治眼(n = 5)的平均BCVA分别提高了+1.57±0.88字母(p = 0.051)和+12.50±8.14字母(p = 0.185),平均CST从基线分别降低了-25.51±5.82 µm(p < 0.001)和-82.60±36.20 µm。从阿柏西普转换治疗的难治性眼(n = 79)中,平均BCVA提高了+2.15±1.08字母(p = 0.029),平均CST降低了-27.46±7.04 µm(p < 0.001)。即使在既往接受过治疗的眼中,首次和第三次法西单抗注射之间,平均色素上皮脱离(PED)也显著降低(p = 0.03)。从阿柏西普转换治疗后,所有眼和难治性眼中视网膜内液和视网膜下液的眼比例均显著改善。170只眼中有3只报告了眼部AE,1例患者在法西单抗治疗期间发生了2次中风事件。

结论

即使在平均给药间隔超过6周的难治性nAMD眼中,三次玻璃体内注射法西单抗仍有可能提高视力和解剖学参数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aca1/11694016/a91802a6fc26/OPTH-18-4029-g0001.jpg

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