RIBOMIC USA Inc, Berkeley, CA, USA.
RIBOMIC Inc., Minato-ku, Tokyo, Japan.
Eye (Lond). 2024 Apr;38(6):1149-1154. doi: 10.1038/s41433-023-02849-6. Epub 2023 Dec 1.
To evaluate the efficacy and safety of a single-dose intravitreal umedaptanib pegol (anti-FGF2, investigational new drug) for the treatment of neovascular age-related macular degeneration (nAMD).
Nine participants who had a diagnosis of refractory nAMD were enrolled and received a single intravitreal injection of umedaptanib pegol at increasing doses of 0.2, 1.0 or 2.0 mg in the study eye.
All three doses of umedaptanib pegol evaluated in the study were safe and well tolerated. No severe adverse event (AE) was observed in the study. There was an improvement in retinal fluid measured by central subfield thickness (CST) in most subjects. Remarkably, all three subjects who received 2.0 mg/eye showed improvement of more than 150 μm.
Intravitreal umedaptanib pegol was safe, well tolerated, and demonstrated an indication of bioactivity in participants that have persistent subretinal fluid refractory to the treatment with anti-VEGFs.
评估单剂量玻璃体内注射 umedaptanib pegoli（抗 FGF2，研究性新药）治疗新生血管性年龄相关性黄斑变性（nAMD）的疗效和安全性。
纳入 9 名诊断为难治性 nAMD 的参与者，在研究眼中接受递增剂量的 0.2、1.0 或 2.0mg 单剂量玻璃体内注射 umedaptanib pegoli。
研究中评估的三种剂量的 umedaptanib pegoli 均安全且耐受良好。研究中未观察到严重不良事件（AE）。大多数受试者的中央视网膜厚度（CST）测量的视网膜液均有改善。值得注意的是，所有接受 2.0mg/眼治疗的 3 名受试者的改善均超过 150μm。
玻璃体内注射 umedaptanib pegoli 安全、耐受良好，并在对抗 VEGF 治疗有反应的持续性眼后液患者中显示出生物活性的迹象。
