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

JRCT ID: jRCT2011230042

Registered date:04/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central Retinal Artery Occlusion
• Date of first enrollment: 08/02/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Administration of SJP-0008 or Placebo, and blood collection

Outcome(s)

• Primary Outcome: Efficacy
• Secondary Outcome: Efficacy and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Akira Ohtori
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development