Table 2.
Study schedule for patients participating from phase II
| Entry | Study period | Follow-up | Cessation | |||||||||||
| Visit | V1* | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12 | V13 | – |
| Timing (D=day, W=week) | D0 | D1 | D2 | D4 | W1 | W2 | W3 | W4 | W6 | W8 | W10 | W12 | W16 | – |
| Entry | ||||||||||||||
| Informed consent | ○ | |||||||||||||
| Eligibility screen | ○ | ○ | ||||||||||||
| Registration | ○ | |||||||||||||
| Assessments | ||||||||||||||
| Vital signs | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ |
| Height, weight and head circumference | ○ | ○ | ○ | ○ | ○ | |||||||||
| Slit-lamp examination | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ |
| Fundus examination | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |||
| Fundus camera | ○ | ○ | ○ | ○ | ||||||||||
| CBC/blood chemistry test | ○ | ○ | ○ | |||||||||||
| Pharmacokinetics† | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ||||
| Urinalysis | ○ | ○ | ○ | ○ | ○ | |||||||||
| Imaging evaluation of the CNS | ○ | ○ | ○ | |||||||||||
| AEs and ADRs | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
*V1 and V2 can be performed on the same day.
†Blood samples for pharmacokinetic studies will be collected 3 times at any point during the study period. Blood will be drawn at any point up to 4 hours after ripasudil administration.
ADR, adverse drug reaction; AE, adverse event; CBC, complete blood cell count; CNS, central nervous system.