METHODS: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.
RESULTS: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.
CONCLUSIONS: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.
BACKGROUND: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.
方法:这项研究是一个开放标签,单臂,单剂量临床研究,以评估SB11PFS在nAMD或RVO继发黄斑水肿患者中的可用性。四个HCP制备并给予34例患者0.5mgSB11PFSIVT注射。产品使用任务完成情况(总共12个任务)由独立观察者进行评估。在注射研究产品后7天评估安全性。
结果:共纳入34例患者并完成研究。34例(100%)患者成功完成了所有12项任务,没有使用相关的失败。大多数患者(32名患者,94.1%)无不良事件(AE),而2例(5.9%)患者出现3例治疗紧急AE(TEAE),严重程度为轻度至中度.在研究期间没有报告严重或严重的TEAE。
结论:这项研究表明,HCP能够通过IVT注射成功制备和施用SB11PFS。没有发现意外的安全问题。SB11PFS是在视网膜疾病患者中治疗性施用SB11的有希望的替代方案。
背景:ClinicalTrials.gov标识符NCT06176963;EudraCT编号2021-003566-12。