Skip to main content
. 2021 Jul 27;11(7):e047003. doi: 10.1136/bmjopen-2020-047003

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.