Hirakata Toshiaki, Toride Ai, Ashikaga Kenta, Nakagawa Takanori, Hara Fumihiro, Nochi Yuta, Yamamoto Shutaro, Hiratsuka Yoshimune, Nakao Shintaro
Department of Ophthalmology, Juntendo University Faculty of Medicine, Hongo 3-1-3, Bunkyo-ku, Tokyo, 113-8431, Japan.
Int J Retina Vitreous. 2025 Jul 15;11(1):79. doi: 10.1186/s40942-025-00703-3.
Faricimab, the new anti-vascular endothelial growth factor (VEGF) drug including a bispecific antibody targeting both VEGF-A and angiopoietin-2 (Ang-2), has emerged as a therapeutic option for macular edema secondary to retinal vein occlusion (RVO), and its efficacy has been demonstrated in randomized controlled trials (RCTs); however, reports on its use in clinical practice are still limited. This study was conducted to evaluate the real-world treatment outcomes of faricimab for macular edema secondary to RVO, managed with a single initial injection plus pro re nata (1 + PRN) approach in both treatment-naïve and previously treated patients who switched to this regimen.
This retrospective observational study included patients diagnosed with branch or central RVO, who received intravitreal faricimab therapy following the 1 + PRN protocol. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) were analyzed.
Thirty patients (17 naïve and 13 switched) were included. The number of IVF was 1.4 ± 0.7 and 2.4 ± 2.1, in the naïve and switch groups, respectively. The mean follow-up period was 3.7 ± 2.7 and 4.9 ± 2.9 months in the naïve and switch patients, respectively. Mean LogMAR BCVA improved in the naïve group from 0.30 ± 0.37 at baseline to 0.11 ± 0.20 (p = 0.01) at the final visit, while there was no significant difference between 0.45 ± 0.45 at baseline and 0.35 ± 0.37 at the final visit in the switch group (p = 0.19). CMT reduction was significant in both groups; from 442 ± 117 μm at baseline to 304 ± 57 μm at one month after final IVF (p < 0.0001) in the naïve group; and from 436 ± 170 μm at baseline to 285 ± 76 μm at one month after final IVF (p = 0.0002) in the switch group.
The 1 + PRN faricimab regimen improves vision and reduces macular edema with a reduced injection burden in patients with RVO. These findings validated the real-world efficacy of faricimab and supported its use as a viable therapeutic agent.
法西单抗是一种新型抗血管内皮生长因子（VEGF）药物，包括一种靶向VEGF-A和血管生成素-2（Ang-2）的双特异性抗体，已成为视网膜静脉阻塞（RVO）继发黄斑水肿的一种治疗选择，其疗效已在随机对照试验（RCT）中得到证实；然而，关于其在临床实践中应用的报道仍然有限。本研究旨在评估法西单抗治疗RVO继发黄斑水肿的真实世界治疗效果，采用单次初始注射加按需（1+PRN）给药方案，对初治患者和改用该方案的既往治疗患者进行治疗。
这项回顾性观察研究纳入了被诊断为分支或中央RVO的患者，这些患者按照1+PRN方案接受玻璃体内注射法西单抗治疗。分析了最佳矫正视力（BCVA）和中心黄斑厚度（CMT）。
共纳入30例患者（17例初治患者和13例改用该方案的患者）。初治组和改用该方案组的玻璃体内注射次数分别为1.4±0.7次和2.4±2.1次。初治患者和改用该方案患者的平均随访时间分别为3.7±2.7个月和4.9±2.9个月。初治组的平均LogMAR BCVA从基线时的0.30±0.37提高到末次随访时的0.11±0.20（p=0.01），而改用该方案组在基线时的0.45±0.45和末次随访时的0.35±0.37之间无显著差异（p=0.19）。两组的CMT均显著降低；初治组从基线时的442±117μm降至末次玻璃体内注射后1个月时的304±57μm（p<0.0001）；改用该方案组从基线时的436±170μm降至末次玻璃体内注射后1个月时的285±76μm（p=0.0002）。
1+PRN法西单抗给药方案可改善RVO患者的视力，减轻黄斑水肿，并减少注射负担。这些结果验证了法西单抗在真实世界中的疗效，并支持其作为一种可行的治疗药物使用。
