Fasler Katrin, Muth Daniel R, Cozzi Mariano, 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 Sep 26;11(10):964. doi: 10.3390/bioengineering11100964.
This study analyzes the dynamics of short-term treatment response to the first intravitreal faricimab injection in eyes with diabetic macular edema (DME). This retrospective, single-center, clinical trial was conducted at the Department of Ophthalmology, University Hospital Zurich. Patients with treatment-naïve and pretreated DME were included. Patient chart data and imaging were analyzed. Safety and efficacy (corrected visual acuity (CVA), central subfield thickness (CST), and signs of intraocular inflammation (IOI)) of the first faricimab intravitreal therapy (IVT) were evaluated weekly until 4 weeks after injection. Forty-three eyes (81% pretreated) of 31 patients were included. Four weeks after the first faricimab IVT, CVA remained stable and median CST (µm) decreased significantly ( < 0.001) from 325.0 (293.5-399.0) at baseline to 304.0 (286.5-358.0). CVA at week 4 was only associated with baseline CVA ( < 0.001). CST was the only predictive variable ( = 0.002) between baseline and week 4 CST. Weekly safety assessments did not show any sign of clinically significant IOI. This study suggests faricimab is an effective treatment for (pretreated) DME, showing structural benefit 1 month following the first injection without short-term safety signals.
本研究分析了糖尿病性黄斑水肿（DME）患者首次玻璃体内注射faricimab后的短期治疗反应动态。这项回顾性单中心临床试验在苏黎世大学医院眼科进行。纳入了未经治疗和经预处理的DME患者。对患者病历数据和影像学资料进行了分析。在首次faricimab玻璃体内治疗（IVT）后每周评估安全性和有效性（矫正视力（CVA）、中心子野厚度（CST）和眼内炎症体征（IOI）），直至注射后4周。纳入了31例患者的43只眼（81%为经预处理的）。首次faricimab IVT后4周，CVA保持稳定，CST中位数（μm）从基线时的325.0（293.5 - 399.0）显著降低（<0.001）至304.0（286.5 - 358.0）。第4周时的CVA仅与基线CVA相关（<0.001）。CST是基线和第4周CST之间唯一的预测变量（=0.002）。每周的安全性评估未显示任何具有临床意义的IOI迹象。本研究表明，faricimab是一种治疗（经预处理的）DME的有效方法，在首次注射后1个月显示出结构改善且无短期安全信号。
