Intravitreal aflibercept (IVT‐AFL) for macular edema secondary to CRVO: Results of COPERNICUS and GALILEO studies

Abstract

Purpose Evaluate efficacy and safety of IVT‐AFL for treatment of macular edema due to CRVO. Methods Patients randomized to IVT‐AFL 2‐mg (IVT‐AFL 2q4) or sham monthly for 24 weeks. COPERNICUS: all patients received IVT‐AFL PRN from week 24‐100 (IVT‐AFL 2q4PRN and shamIVT‐AFL PRN). GALILEO: IVT‐AFL PRN was administered to IVT‐AFL group from week 24‐76 and sham group from week 52‐76. Results Proportion of IVT‐AFL 2q4PRN and shamIVT‐AFL PRN patients gaining ≥15 letters was 56.1% vs 12.3% and 49.1% vs 23.3%, respectively, at week 24 and 100 (COPERNICUS) and 60.2% vs 22.1% and 57.3% vs 29.4%, respectively, at week 24 and 76 (GALILEO; all P<0.01). Mean change in BCVA was +17.3 vs ‐4.0 (P<0.0001) and +13.0 vs +1.5 ETDRS letters (P=0.007) at week 24 and 100 (COPERNICUS) and +18.0 vs +3.3 (P<0.001) and +13.7 vs +6.2 letters (P=0.007) at week 24 and 76 (GALILEO) in IVT‐AFL 2q4PRN and shamIVT‐AFL PRN groups, respectively. Mean reduction from baseline CRT was 457.2 vs 144.8 µm (P<0.001) and 390.0 vs 343.3 µm at week 24 and 100 in COPERNICUS and 448.6 vs 169.3 µm (P<0.0001) and 389.4 vs 306.4 µm at week 24 and 76 in GALILEO in IVT‐AFL 2q4PRN and shamIVT‐AFL PRN groups, respectively. Most frequent ocular SAEs in IVT‐AFL 2q4PRN group were cataract (COPERNICUS) and macular edema (GALILEO). APTC ATEs occurred only in COPERNICUS (2 (1.8%) IVT‐AFL, 2 (2.7%) sham). Conclusion IVT‐AFL treatment resulted in early, sustained VA gains. Maintenance of VA gains with an extended treatment interval after initial monthly dosing depended on monthly monitoring. Long‐term fixed dosing regimens may be a better treatment paradigm. Commercial interest