Central Retinal Artery Occlusion
Conditions
Interventions
Administration of SJP-0008 or Placebo, and blood collection
Sponsors
Akira Ohtori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and safety | — |
Contacts
Public ContactSenju Laboratory of Ocular Sciences
Senju Pharmaceutical Co., Ltd.
Outcome results
None listed