Time-in-range post hoc analysis
The time-in-range calculation concept is shown in Fig. Mean time in range (in weeks) was calculated for a BCVA letter score threshold of ≥69; approximate Snellen equivalent 20/40 (primary analysis) and, in sensitivity analyses, for all thresholds from 100 to 0 (in 1-letter increments), an approximate Snellen equivalent of 20/10 to 20/800, using all BCVA data available over Day 0–364, 365–728, or 0–728, whereby participants were assumed to have the same BCVA value until a newer measurement was performed. Protocol T data through Year 1 were analysed for the primary outcomes of this analysis. Two-year outcomes are provided as supplemental analyses, as more limitations must be considered for the data between 1 and 2 years given the variable follow-up schedule.To determine the effect of the BCVA threshold applied and the effect of the participants’ baseline BCVA on the time-in-range outcome, time in range for the letter score threshold of ≥69 (20/40 or better) and also of ≥59 and ≥79 (20/32 and 20/25 or better) were calculated for the overall population, as well as according to and adjusted for baseline BCVA.Furthermore, in a ‘responder-type’ analysis, the proportion of participants above BCVA letter score threshold of ≥69 (approximate Snellen equivalent 20/40 or better), the “responder threshold” agreed a priori, was calculated for time in range of 0–100% (in 1% increments).The number of BCVA assessments in Year 1 (Day 0–364) and Year 2 (Day 365–728) of Protocol T (Supplementary Table 