Macha Nathan, Yu Minzhong, Sapieha Przemyslaw, Klier Sharon, Ghosh Anirvan, White Lorraine, Maturi Raj K
Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
Retina Partners Midwest, and Midwest Eye Institute, Carmel, IN 46290, USA.
J Clin Med. 2024 Sep 19;13(18):5540. doi: 10.3390/jcm13185540.
: The objective of this study was to determine the treatment effect of foselutoclax in neovascular age-related macular degeneration (AMD) by multifocal electroretinography (mfERG) and evaluate mfERG as a potential clinical endpoint in AMD studies. : A total of five subjects were included in the study who had active choroidal neovascularization and a history of at least two anti-vascular endothelial growth factor (VEGF) injections in the last 6 months. Subjects received a 50 µL intravitreal injection of foselutoclax at the baseline visit and Weeks 4, 24, and 28 of the study period. : After foselutoclax treatment, the largest improvement in the mfERG N1-P1 response density occurred at Week 8 as three of five subjects achieved a ≥20% gain. In addition, three of five subjects demonstrated a BCVA improvement of ≥5 ETDRS letters over baseline at Weeks 4, 8, and 24. The mean change in BCVA demonstrated statistical significance in Weeks 4 and 8, showing increases of 5 ( = 0.02) and 6.2 ( = 0.02) letters, respectively. : Foselutoclax treatment was shown to have the potential to recover outer retinal function as determined by mfERG and BCVA at approximately Week 8 of treatment.
本研究的目的是通过多焦视网膜电图（mfERG）确定福塞鲁托拉克在新生血管性年龄相关性黄斑变性（AMD）中的治疗效果，并评估mfERG作为AMD研究中潜在临床终点的价值。本研究共纳入5名受试者，他们有活动性脉络膜新生血管，且在过去6个月内至少接受过两次抗血管内皮生长因子（VEGF）注射。受试者在基线访视以及研究期的第4周、24周和28周接受50µL玻璃体内注射福塞鲁托拉克。福塞鲁托拉克治疗后，mfERG的N1 - P1反应密度最大改善出现在第8周，5名受试者中有3名实现了≥20%的增益。此外，5名受试者中有3名在第4周、8周和24周时最佳矫正视力（BCVA）较基线提高了≥5个ETDRS字母。BCVA的平均变化在第4周和第8周具有统计学意义，分别增加了5（P = 0.02）和6.2（P = 0.02）个字母。福塞鲁托拉克治疗显示出在治疗约第8周时通过mfERG和BCVA确定的恢复视网膜外层功能的潜力。
