Endpoints
treatment-emergent adverse, Diabetic Retinopathy
ADVERSE EVENTS, DIABETIC RETINOPATHY
The primary endpoint was the mean change in BCVA in Early Treatment Diabetic Retinopathy Study (ETDRS) letters or any visual logarithmic scale from baseline to month 12; these results and a subgroup analysis thereof have previously been published [Secondary outcomes included the mean change in BCVA from baseline to months 24, 36, and 48; the percentage of patients who experienced a BCVA gain of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, and ≥ 15 letters from baseline to months 24, 36, and 48; the percentage of patients who maintained vision (defined as a BCVA loss of < 15 letters) at months 24, 36, and 48; and the mean number of injections and visits over the study period. Safety was monitored throughout the study. All adverse events reported after the first IVT-AFL treatment and up to 30 days after the last IVT-AFL treatment were documented as treatment-emergent adverse events.