臨床研究等提出・公開システム

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

Placebo-Controlled, Parallel-Group Study of SJP-0008 in Participants with Central Retinal Artery Occlusion

Akira Ohtori

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

clinical-trial-slos@senju.co.jp

Senju Laboratory of Ocular Sciences

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

+81-78-777-1020

clinical-trial-slos@senju.co.jp

Not Recruiting

Jan. 09, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

Both

Central Retinal Artery Occlusion

Administration of SJP-0008 or Placebo, and blood collection

Efficacy

Efficacy and safety

+81-11-706-7061

Nov. 20, 2023

No

none