Treatment pattern and exposure
PREMATURE
Of the 411 of 516 patients in the FAS with a BCVA assessment at months 0 and 12, 102 patients (24.8%) were treated regularly with IVT-AFL and comprised the regular treatment cohort, whereas the remaining 309 patients were treated irregularly. Of the 309 irregularly treated patients, 253 (81.9%) received the 3 initial monthly injections and 56 (18.1%) did not.In the overall FAS, the mean ± SD duration of treatment with IVT-AFL (defined as the mean time between the first and last IVT-AFL injections) was 29.4 ± 18.2 months, with a median of 32.9 months. Based on Kaplan–Meier estimates, 91.0% of patients in the FAS completed 3 months of IVT-AFL treatment, 75.1% completed 12 months, 55.2% completed 24 months, 45.5% completed 36 months, and 30.2% completed 48 months. Premature discontinuation from the study (A total of 414 of 516 patients (80.2%) in the FAS received the 3 initial injections within the first 45–90 days after treatment initiation (i.e., after the first injection in month 0). Notably, the early discontinuation rate was significantly higher (Estimated rate of persistence with intravitreal aflibercept up to year 4In the overall FAS, the mean duration of follow-up after the first injection of IVT-AFL was 38.7 ± 15.3 months (median, 47.6 months); 306 patients (59.3%) were followed-up for ≥ 45 months. The duration of follow-up was defined as the time from study entry to the last visit performed, where the last visit did not necessarily need to involve a treatment and could have been a monitoring visit only.During the follow-up period, 97 patients (18.8%) in the FAS discontinued because they switched from IVT-AFL and received another anti-VEGF agent or laser photocoagulation/photodynamic therapy and stopped IVT-AFL (or only resumed IVT-AFL > 3 months after the procedure). Most patients who switched treatment received another anti-VEGF, with 91/95 switching to ranibizumab; the main reason for switching was lack of efficacy (The overall annualized rate of visits (mean [95% CI]) in the FAS was higher during the first year of treatment than in subsequent years (year 1, 9.83 [9.55–10.11]; year 2, 7.05 [6.81–7.31]; year 3, 6.70 [6.44–6.96]; year 4, 6.89 [6.61–7.18]). The overall annualized rate of injections in year 1 was 6.27 (95% CI, 6.05–6.50), and this rate decreased and remained relatively similar in subsequent years: 3.45 (3.28–3.63) in year 2, 3.20 (3.02–3.38) in year 3, and 3.35 (3.16–3.55) in year 4. There was no correlation between the annualized rate of injections in year 1 and BCVA score at baseline (data not shown). The number of injections and visits according to IVT-AFL treatment cohort is shown in Table Mean number of visits and IVT-AFL injections from baseline to 12 months and 48 months for the overall FAS and each IVT-AFL treatment cohortValues are mean ± SD. The regular and irregular cohorts include only those patients from the FAS with a BCVA assessment at baseline and month 12. 