治疗新生血管性年龄相关性黄斑变性新患者的玻璃体内法尼单抗:一项真实世界前瞻性研究。

Gabriela Grimaldi, Giuseppe Cancian, Arianna Paris, Michele Clerici, Giulio Volpe, Moreno Menghini
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引用次数: 0

摘要

背景:法尼单抗是一种同时靶向血管生成素-2(Ang-2)和血管内皮生长因子-A(VEGF-A)的双特异性抗体,最近被用于治疗新生血管性老年黄斑变性(nAMD)、糖尿病性黄斑水肿和视网膜静脉闭塞继发的囊样黄斑水肿。我们的研究旨在评估玻璃体内法尼单抗在治疗无效的 nAMD 患者队列中的疗效、安全性和持久性:2022年10月至2024年4月期间,对19名治疗无效的nAMD患者的21只眼睛进行了玻璃体内法尼单抗治疗。患者接受了每月 4 次法尼单抗注射的负荷剂量 (LD),随后接受了治疗和延长方案。主要结果包括最佳矫正视力(BCVA)和光谱域光学相干断层扫描(SD-OCT)的结构参数。次要结果包括达到干性黄斑的眼睛比例、最大无液间隔和最后一次随访时的预期间隔:研究包括 19 名患者的 21 只眼睛(平均年龄 83.1 岁)。LD 后,93.3% 的眼睛在 8 周的中位时间内完成了干黄斑 SD-OCT 扫描。在第一次延期时,53% 的眼睛仍保持干燥,而 47% 的眼睛再次出现积液。长期分析(n = 14)显示,在中位 64.9 周的随访中,黄斑体积 (MV)、中央子野厚度 (CST) 和色素上皮脱落 (PED) 高度均显著降低,视觉和解剖结构也得到持续改善。最终随访的 BCVA、CST 和 MV 中位数与基线相比均有显著改善(p 结论:BCVA、CST 和 MV 中位数与基线相比均有显著改善):法尼单抗玻璃体内注射液在治疗无效的 nAMD 患者队列中显示出良好的疗效、安全性和持久性。
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Intravitreal faricimab for treatment naïve patients with neovascular age-related macular degeneration: a real-world prospective study.

Background: Intravitreal faricimab, a bispecific antibody targeting both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), was recently introduced for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular oedema and cystoid macular oedema secondary to retinal vein occlusion. The aim of our study was to assess the efficacy, safety and durability of intravitreal faricimab in a real-world cohort of treatment-naïve patients with nAMD.

Methods: Single-centre, prospective cohort study of 21 eyes from 19 treatment-naïve nAMD patients who were treated with intravitreal faricimab from October 2022 to April 2024. Patients underwent a loading dose (LD) of 4 monthly faricimab injections followed by a treat-and-extend regimen. Primary outcomes included best-corrected visual acuity (BCVA) and structural parameters from spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes included the proportion of eyes achieving a dry macula, maximal fluid-free interval and intended interval at last follow-up.

Results: The study included 21 eyes of 19 patients (mean age 83.1 years). After LD, 93.3% of eyes achieved a dry macular SD-OCT scan within a median time of 8 weeks. At the first extension, 53% of eyes remained dry, while 47% showed fluid recurrence. Long-term analysis (n = 14) revealed significant reductions in macular volume (MV), central subfield thickness (CST), and pigment epithelial detachment (PED) height over a median follow-up of 64.9 weeks, with sustained visual and anatomical improvements. Median BCVA, CST, and MV at the final follow-up were significantly improved from baseline (p < 0.01). The intended interval between injections was ≥ 12 weeks in 42.86% of eyes. No cases of intraocular inflammation were observed, although 10% experienced retinal pigment epithelial tears.

Conclusions: Intravitreal faricimab demonstrated favourable efficacy, safety, and durability outcomes in a real-world cohort of treatment-naïve nAMD patients.

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来源期刊
CiteScore
3.50
自引率
4.30%
发文量
81
审稿时长
19 weeks
期刊介绍: International Journal of Retina and Vitreous focuses on the ophthalmic subspecialty of vitreoretinal disorders. The journal presents original articles on new approaches to diagnosis, outcomes of clinical trials, innovations in pharmacological therapy and surgical techniques, as well as basic science advances that impact clinical practice. Topical areas include, but are not limited to: -Imaging of the retina, choroid and vitreous -Innovations in optical coherence tomography (OCT) -Small-gauge vitrectomy, retinal detachment, chromovitrectomy -Electroretinography (ERG), microperimetry, other functional tests -Intraocular tumors -Retinal pharmacotherapy & drug delivery -Diabetic retinopathy & other vascular diseases -Age-related macular degeneration (AMD) & other macular entities
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