SJP-0008 Phase III Study -A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study in Participants with Central Retinal Artery Occlusion-

Senju Pharmaceutical Co., Ltd.0 个研究点目标入组 60 人开始时间: 2024年2月8日最近更新: 2025年3月18日

适应症

试验速览

暂无简介。

•Japanese Outpatients aged over 20 years at the time of signing informed consent (any gender)
•Patient with non-arteritic Central Retinal Artery Occlusion
•Investigational Product will be administered within 3 to 48 hours after the onset of Central Retinal Artery Occlusion
•BCVA of the target eye is better than Hand Motion and worse than logMAR 1.0 (equivalent to decimal visual acuity of less than 0.1)
•Other protocol-defined inclusion criteria may apply

•The target eye have retinal diseases that may progress and/or require treatments, or diseases that seriously affect visual function
•Have a history of intraocular surgery in the target eye
•BCVA of the non-target eye is worse than logMAR 1.0 (equivalent to decimal visual acuity of less than 0.1)
•Have used any of the following prohibited concomitant drug within the last 14 days of starting IP administration, or will continue to use it during the treatment period
•> Strong CYP3A inhibitors and moderate CYP3A inhibitors
•> Food containing grapefruit
•Have used any of the following prohibited concomitant drug within the last 28 days of starting IP administration, or will continue to use it during the treatment period
•> CYP3A inducer
•> St john's wort
•Have cancer, serious systemic disease, dementia or depression
•Other protocol-defined exclusion criteria may apply

Efficacy

未报告次要终点

发起方