Department of Ophthalmology and Visual Science, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima 734-8551, Japan.
Medicina (Kaunas). 2023 Jun 11;59(6):1125. doi: 10.3390/medicina59061125.
: Faricimab is the first intravitreal injection of vascular endothelial growth factor-A and angiopoietin-2 bispecific monoclonal antibody. Here, we evaluate the functional and anatomical outcomes of faricimab treatment in patients with diabetic macular edema (DME) that was refractory to ranibizumab or aflibercept. : We performed a retrospective, observational, consecutive-case study of patients who had DME that was refractory to treatment with ranibizumab or aflibercept and were treated with faricimab between July 2022 and January 2023 under a pro re nata regimen. All the participants were followed for ≥4 months after the initiation of faricimab. The primary outcome was a recurrence interval of ≥12 weeks, and the secondary outcomes were the changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). : We analyzed 18 eyes of 18 patients. The mean recurrence interval of previous anti-VEGF injection was 5.8 ± 2.5 weeks, which was significantly extended to 10.8 ± 4.9 weeks ( = 0.0005) by the switch to faricimab. Eight patients (44.4%) achieved a recurrence interval of ≥12 weeks. A history of subtenon injection of triamcinolone acetonide ( = 0.0034) and the presence of disorganization of the retinal inner layers ( = 0.0326) were found to be significantly associated with a recurrence interval of <12 weeks. The mean BCVAs were 0.23 ± 0.28 logMAR and 0.19 ± 0.23 logMAR, and the mean CMTs were 473.8 ± 222.0 µm and 381.3 ± 219.4 µm at baseline and 4 months, respectively, but these changes were not statistically significant. None of the patients experienced serious adverse events. : Faricimab may extend the treatment interval for patients with DME that is refractory to ranibizumab or aflibercept. DME previously treated with the subtenon injection of triamcinolone acetonide or associated with disorganization of the retinal inner layers may be less likely to be associated with a longer recurrence interval after switching to faricimab.
法替西单抗是一种血管内皮生长因子-A 和血管生成素-2 双特异性单克隆抗体的玻璃体腔内注射药物。在这里,我们评估了法替西单抗治疗对接受雷珠单抗或阿柏西普治疗后仍有抵抗的糖尿病性黄斑水肿(DME)患者的功能和解剖学结局。
我们进行了一项回顾性、观察性、连续病例研究,纳入了 2022 年 7 月至 2023 年 1 月期间,根据需要接受法替西单抗治疗的、对雷珠单抗或阿柏西普治疗有抵抗的 DME 患者。所有参与者在开始接受法替西单抗治疗后至少随访 4 个月。主要结局是复发间隔≥12 周,次要结局是最佳矫正视力(BCVA)和中心黄斑厚度(CMT)的变化。
我们分析了 18 例 18 只眼。先前抗 VEGF 注射的平均复发间隔为 5.8±2.5 周,而转换用法替西单抗后显著延长至 10.8±4.9 周(=0.0005)。8 例(44.4%)患者达到了≥12 周的复发间隔。既往曲安奈德眼周注射(=0.0034)和视网膜内层结构紊乱(=0.0326)与复发间隔<12 周显著相关。基线时和 4 个月时的平均 BCVA 分别为 0.23±0.28 logMAR 和 0.19±0.23 logMAR,平均 CMT 分别为 473.8±222.0 µm 和 381.3±219.4 µm,但这些变化无统计学意义。无患者发生严重不良事件。
法替西单抗可能延长对雷珠单抗或阿柏西普有抵抗的 DME 患者的治疗间隔。先前接受曲安奈德眼周注射或伴有视网膜内层结构紊乱的 DME 患者,在转换用法替西单抗后可能不太容易出现复发间隔延长。