Visual acuity outcomes by baseline perfusion status in the COPERNICUS and GALILEO trials

Purpose To assess the impact of baseline perfusion status on best‐corrected visual acuity (BCVA) in patients with macular edema due to central retinal vein occlusion treated with intravitreal aflibercept (IVT‐AFL) injection. Methods Patients received IVT‐AFL 2 mg (IVT‐AFL 2q4) or sham monthly up to Week 24 (W24). From W24‐W52, all IVT‐AFL–treated patients in both studies and sham‐treated patients in COPERNICUS were eligible to receive IVT‐AFL based on visual and anatomical outcomes (IVT‐AFL 2q4+PRN, sham+IVT‐AFL PRN). Sham‐treated patients in GALILEO were eligible to receive IVT‐AFL after W52. Retinal perfusion (<10 disc areas of nonperfusion) was assessed at baseline, W12, and W24 . Macular perfusion was not assessed. Results COPERNICUS: In the baseline perfused group, mean BCVA change from baseline at W24, W52, and W100 was 17.1, 16.2, and 12.4 letters for IVT‐AFL2q4+PRN and ‐4.8, 2.9, and 0.5 letters for sham+IVT‐AFL PRN. In the baseline nonperfused group, mean BCVA change was 17.8, 16.0, and 14.2 letters for IVT‐AFL2q4+PRN and ‐2.3, 5.9, and 3.7 letters for sham+IVT‐AFL PRN. GALILEO: In the baseline perfused group, mean BCVA change from baseline at W24, W52, and W76 was 17.8, 16.8, and 13.6 letters for IVT‐AFL2q4+PRN and 6.0, 6.8, and 9.1 letters for sham+IVT‐AFL PRN. In the baseline nonperfused group, mean BCVA change was 17.1, 12.7, and 8.6 letters for IVT‐AFL2q4+PRN and ‐11.7, ‐13.0, and ‐9.7 letters for sham+IVT‐AFL PRN. In the overall populations, the most common ocular SAEs in IVT‐AFL2q4+PRN patients were cataract (COPERNICUS) and macular oedema (GALILEO). Conclusion Both perfused and nonperfused patients treated with IVT‐AFL experienced similar gains in BCVA. Baseline perfusion status may not deter success in treatment with IVT‐AFL.Commercial interest