Muth Daniel R, Fasler Katrin F, Kvanta Anders, Rejdak Magdalena, Blaser Frank, Zweifel Sandrine A
Department of Ophthalmology, University Hospital Zurich, University of Zurich, 8091 Zurich, Switzerland.
Division of Eye and Vision, Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.
Bioengineering (Basel). 2024 May 10;11(5):478. doi: 10.3390/bioengineering11050478.
: This study entailed a weekly analysis of real-world data (RWD) on the safety and efficacy of intravitreal (IVT) faricimab in neovascular age-related macular degeneration (nAMD). : A retrospective, single-centre clinical trial was conducted at the Department of Ophthalmology, University Hospital Zurich, University of Zurich, Switzerland, approved by the Cantonal Ethics Committee of Zurich, Switzerland. Patients with nAMD were included. Data from patient charts and imaging were analysed. The safety and efficacy of the first faricimab injection were evaluated weekly until 4 weeks after injection. : Sixty-three eyes with a complete 4-week follow-up were enrolled. Six eyes were treatment-naïve; fifty-seven eyes were switched to faricimab from another treatment. Neither group showed signs of retinal vasculitis during the 4 weeks after injection. Central subfield thickness (CST) and volume (CSV) showed a statistically significant decrease compared to the baseline in the switched group (CST: = 0.00383; CSV: = 0.00702) after 4 weeks. The corrected visual acuity returned to the baseline level in both groups. The macular neovascularization area decreased in both groups, but this was not statistically significant. A complete resolution of sub- and intraretinal fluid after 4 weeks was found in 40% (switched) and 75% (naïve) of the treated patients. : The weekly follow-ups reflect the structure-function relationship beginning with a fast functional improvement within two weeks after injection followed by a return to near-baseline levels after week 3. The first faricimab injection in our cohort showed a high safety profile and a statistically significant reduction in macular oedema in switched nAMD patients.
本研究对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)的安全性和有效性进行了每周一次的真实世界数据(RWD)分析。在瑞士苏黎世大学苏黎世大学医院眼科进行了一项回顾性单中心临床试验,该试验获得了瑞士苏黎世州伦理委员会的批准。纳入了nAMD患者。对患者病历和影像学数据进行了分析。每周评估首次注射法西单抗后的安全性和有效性,直至注射后4周。共纳入63只完成4周随访的眼睛。6只眼睛为初治患者;57只眼睛从其他治疗方案转换为法西单抗治疗。两组在注射后4周内均未出现视网膜血管炎迹象。转换组在4周后,中心子野厚度(CST)和体积(CSV)与基线相比有统计学意义的下降(CST: = 0.00383;CSV: = 0.00702)。两组的矫正视力均恢复到基线水平。两组的黄斑新生血管面积均减小,但差异无统计学意义。40%(转换组)和75%(初治组)的治疗患者在4周后视网膜下和视网膜内液完全消退。每周的随访反映了结构-功能关系,即注射后两周内功能迅速改善,随后在第3周后恢复到接近基线水平。在我们的队列中,首次注射法西单抗显示出较高的安全性,并且转换治疗的nAMD患者黄斑水肿有统计学意义的减轻。