Valley Retina Institute, McAllen, TX, USA.
Retina Research Center, Austin, TX, USA.
Transl Vis Sci Technol. 2021 Dec 1;10(14):27. doi: 10.1167/tvst.10.14.27.
Carotuximab (DE-122) is a novel endoglin antibody that exhibits potent anti-angiogenic activity. The aim of this study was to evaluate the safety and tolerability of a single intravitreal injection of four ascending doses of carotuximab in patients with persistent exudative age-related macular degeneration (AMD).
In an open-label, dose-escalating, sequential cohort study, patients with persistent exudative AMD were assigned to an intravitreal injection of carotuximab 0.5 mg, 1.0 mg, 2.0 mg, or 4.0 mg (n = 3 per group). Safety and change in central subfield thickness (CST), as measured by spectral domain-optical coherence tomography, were assessed from baseline until day 90. Rescue therapy with an anti-vascular endothelial growth factor medication was allowed on days 8, 30, and 60.
Seven patients (58%) experienced at least one adverse event (AE), including five patients (41.7%) who experienced one or more AEs in the study eye and two patients (16.7%) who experienced one or more non-ocular AEs. Posterior eye deposits were reported in one patient 2 days after receiving 1.0 mg, but they resolved spontaneously by day 43. A >50-µm reduction in CST on two consecutive visits was observed in four patients (33%), including one patient in each dose cohort.
In this study, carotuximab was generally well tolerated, with no serious AEs reported, when administered as a single intravitreal injection to patients with persistent exudative AMD.
Further characterization of the safety and efficacy of carotuximab will be needed to determine what role it may have in the treatment of exudative AMD.
Carotuximab（DE-122）是一种新型的内胚层素抗体，具有很强的抗血管生成活性。本研究旨在评估单次玻璃体内注射递增剂量的 carotuximab 治疗持续性渗出性年龄相关性黄斑变性（AMD）患者的安全性和耐受性。
在一项开放性、剂量递增、序贯队列研究中，将持续性渗出性 AMD 患者分为玻璃体内注射 carotuximab 0.5mg、1.0mg、2.0mg 或 4.0mg（每组 3 例）。从基线到第 90 天，通过光谱域光学相干断层扫描评估中央视网膜下厚度（CST）的变化和安全性。允许在第 8、30 和 60 天使用抗血管内皮生长因子药物进行抢救治疗。
7 名患者（58%）出现至少 1 种不良事件（AE），包括 5 名（41.7%）研究眼中出现 1 种或多种 AE 的患者和 2 名（16.7%）出现 1 种或多种非眼部 AE 的患者。1 名患者在接受 1.0mg 后 2 天出现后眼部沉积物，但在第 43 天自发消退。4 名患者（33%）连续两次就诊时 CST 减少≥50μm，包括每个剂量组各 1 名患者。
在本研究中，carotuximab 作为单一玻璃体内注射药物用于持续性渗出性 AMD 患者时，通常具有良好的耐受性，未报告严重不良事件。
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