6533b7dbfe1ef96bd127096f

RESEARCH PRODUCT

Vision-related function in the COPERNICUS and GALILEO trials

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description

Purpose To examine the impact of intravitreal aflibercept (IVT-AFL) injection on the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ) in the COPERNICUS and GALILEO trials. Methods Patients (pts) with macular oedema secondary to central retinal vein occlusion received IVT-AFL 2 mg (IVT-AFL 2q4) or sham monthly for 24 weeks. After Week 24 (W24) in COPERNICUS all pts were eligible to receive IVT-AFL based on visual and anatomical outcomes (IVT-AFL 2q4+PRN, sham+IVT-AFL PRN). In GALILEO, sham-treated pts received sham tx until W52. The NEI VFQ was administered at baseline (BL), W24 and W52. Total and subscale scores were compared between groups. W24 data were integrated and W52 data were analysed by study. Results Mean change from BL to W24 in total score was greater in the IVT-AFL 2q4+PRN than the sham group (7.3 vs 2.2, p<0.0001). Mean changes from BL to W24 were greater in the IVT-AFL 2q4+PRN group vs sham for near activities, distance activities, and dependency. In both studies, the mean change from BL to W52 in total score was greater in the IVT-AFL 2q4+PRN than in the sham+IVT-AFL PRN or sham groups (COPERNICUS: 7.9 vs 4.5, p=0.0049, GALILEO: 7.5 vs 5.1, p=0.2164). In both studies, mean changes from BL to W52 were greater in the IVT-AFL 2q4+PRN than the sham and sham+IVT-AFL PRN groups for near activities, distance activities, and dependency. The most common ocular SAEs in IVT-AFL2q4+PRN pts were cataract (COPERNICUS) and macular oedema (GALILEO). Conclusion Pts in the IVT-AFL 2q4+PRN group experienced clinically meaningful improvements (typically defined as an increase of ≥4 points) from BL to W24 and BL to W52 in total and subscale NEI VFQ scores. Changes with IVT-AFL 2q4+PRN were greater than those in the sham and sham+IVT-AFL PRN groups. Commercial interest