The primary endpoint was treatment success rate at 12 months (defined as a gain of ≥1 letter in BCVA and/or any decrease in CRT [in μm] between initial visit [first injection of IVT-AFL] and 12-month follow-up visit). BCVA was measured using ETDRS letters (preferentially) or any other visual scale. For data analysis, we transformed any other visual acuity score to ETDRS letter score.

Secondary outcomes included change in BCVA between baseline and final study visits (12 months after the first injection of IVT-AFL or study discontinuation), mean duration of ranibizumab treatment before initiation of IVT-AFL, and frequency and mean number of IVT-AFL injections over the study period. No BCVA data were collected at the end of ranibizumab treatment; however, switching to IVT-AFL occurred relatively soon after the last ranibizumab injection (median of 44.0 days). Therefore, the change in BCVA during ranibizumab treatment was estimated based on the change between BCVA values before any treatment and before first injection of IVT-AFL.

All adverse events (AEs) occurring after the first IVT-AFL injection were documented in the electronic case report form. All patient medical records were evaluated for demographic as well as clinical characteristics, and AEs were summarised using the Medical Dictionary for Regulatory Activities coding system. The event rates for single AEs were calculated based on the total number of documented patients and AEs were categorised according to connection with medication, seriousness, discontinuation of therapy and outcome.

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