Item | Screening | Observation period | ||||||
---|---|---|---|---|---|---|---|---|
Cycle 1 | Cycle 2 | Cycle 3 | Closeout | |||||
Time point | Enrollment | Weeks 1–8 | Weeks 9–16 | Weeks 17–24 | Weeks 25–32 | Weeks 33–40 | Weeks 41–48 | |
Demographic data | √ | |||||||
Medical history | √ | |||||||
Informed consent form | √ | |||||||
BCVA | √ | √ | √ | √ | √ | √ | √ | |
VF | √ | √ | √ | √ | √ | √ | √ | |
OCT | √ | √ | √ | √ | √ | √ | √ | |
FAF | √ | √ | √ | √ | √ | √ | √ | |
ERG | √ | √ | √ | √ | √ | √ | √ | |
NEI VFQ-25 | √ | √ | √ | √ | √ | √ | √ | |
Adverse event | √ | √ | √ | √ | √ | √ |