Outcome Measures

The primary outcome of the study was the mean absolute change from baseline CST at month 12 as measured by SD-OCT (defined as the average thickness within the central 1-mm subfield). Secondary outcomes included the mean change from baseline in ETDRS BCVA scores, OCTA capillary perfusion density (CPD) changes (Figure 1), DR severity changes as determined by clinical examination, and adverse events (AEs) at months 6, 12, and 24.

Representative patient who had a decrease in superficial and deep capillary perfusion density (CPD) from baseline to 12 months. CST, central subfield thickness.