Tsilegeridis-Legeris Theodore, Kenawy Nihal
Ophthalmology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, GBR.
Cureus. 2025 Aug 7;17(8):e89526. doi: 10.7759/cureus.89526. eCollection 2025 Aug.
Objective To determine real-world clinical outcomes (including vision, anatomy and durability) of intravitreal faricimab (IVF) in year two (up to mean follow-up of 75 ± 15 weeks, range: 52-103 weeks) of treating diabetic macular oedema (DMO). Secondary objectives included assessing changes in diabetic retinopathy (DR) severity, the incidence of epiretinal proliferation (ERP)/epiretinal membrane (ERM), and safety. Methodology This is a single-centre retrospective observational study. Eligible eyes with ≥52 weeks follow-up, October 2022 to November 2024, were identified and categorised into naïve (no prior anti-vascular endothelial growth factor (anti-VEGF) agents) and switch (≥1 prior anti-VEGF). Descriptive statistics at week 52 (W52) and end of follow-up (EOFU) summarised mean BCVA and CFT change, mean IVF injections and frequency, DR severity change, epiretinal proliferation (ERP)/membrane (ERM) incidence, and safety. Results In total, 158 eyes (66 naïve, 92 switch) of 118 patients were identified, mean follow of 75 weeks. Mean W52 BCVA change was +3.6 (= 0.04) for naïve and +1.3 letters (= 0.34) for switch eyes; mean CFT reduction was -141 μm (< 0.0001) and -115 μm (< 0.0001), respectively. At EOFU, 27 (63%) naïve eyes and 36 (55%) switch eyes received IVF ≥12 weekly. In switch eyes, the mean W52 IVF interval was 11 weeks versus 7 with prior anti-VEGF agents (< 0.0001). Of 115 available images, DR severity regressed or was stable in 111 (97%). ERP/ERM was developed in 10/39 (25.6%) naïve and 14/41 (34.1%) switch eyes. No safety outcomes were ever reported. Conclusions Faricimab demonstrated significant structural improvement and durability, with BCVA stability maintained into the second year of treatment. Most eyes showed regression or stability of DR with moderate ERP/ERM incidence.
目的 确定玻璃体内注射法西单抗（IVF）治疗糖尿病性黄斑水肿（DMO）第二年（平均随访75±15周，范围：52 - 103周）的真实世界临床结局（包括视力、解剖结构和耐用性）。次要目标包括评估糖尿病视网膜病变（DR）严重程度的变化、视网膜前增殖（ERP）/视网膜前膜（ERM）的发生率以及安全性。方法 这是一项单中心回顾性观察研究。确定了2022年10月至2024年11月随访时间≥52周的符合条件的眼睛，并将其分为初治组（未使用过抗血管内皮生长因子（anti - VEGF）药物）和转换组（至少使用过1种抗VEGF药物）。在第52周（W52）和随访结束时（EOFU）的描述性统计总结了平均最佳矫正视力（BCVA）和中央黄斑厚度（CFT）变化、平均IVF注射次数和频率、DR严重程度变化、视网膜前增殖（ERP）/膜（ERM）发生率以及安全性。结果 共确定了118例患者的158只眼睛（66只初治组，92只转换组），平均随访75周。初治组眼睛W52时BCVA平均变化为+3.6字母（= +0.0视力），转换组眼睛为+1.3字母（= +0.03视力）；CFT平均降低分别为-141μm（< 0.0001）和-115μm（< 0.0001）。在EOFU时，27只（占63%）初治组眼睛和36只（占55%）转换组眼睛接受了每周至少1次的IVF注射。在转换组眼睛中，W52时IVF的平均间隔时间为11周，而使用过抗VEGF药物时为7周（< 0.0001）。在115张可用图像中，111只（占97%）眼睛的DR严重程度有所改善或保持稳定。初治组39只眼睛中有10只（占25.6%）、转换组41只眼睛中有14只（占34.1%）出现了ERP/ERM。未报告任何安全问题。结论 法西单抗显示出显著的结构改善和耐用性，在治疗的第二年BCVA仍保持稳定。大多数眼睛的DR有所改善或保持稳定，ERP/ERM发生率中等
