PSS5 - VISION-RELATED QUALITY OF LIFE IN PATIENTS WITH DIABETIC MACULAR EDEMA TREATED WITH INTRAVITREAL AFLIBERCEPT: THE AQUA STUDY

Abstract

To examine vision-related quality of life in patients with diabetic macular edema treated with intravitreal aflibercept (IVT-AFL). AQUA was a multicentre, open-label, single-arm, Phase 4 study. Patients were administered monthly IVT-AFL 2 mg for an initial 5 months followed by injections every 8 weeks to Week 52. The primary endpoint was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) total score from baseline to Week 52. Secondary endpoints included change in the NEI-VFQ-25 near/distant activities subscales, change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), proportion of patients progressing to ≥ 61 ETDRS DRSS, and change in central retinal thickness (CRT) from baseline to Week 52. 553 patients comprised the full analysis set and 560 comprised the safety analysis set. At baseline, mean NEI-VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At Week 52, mean (SD) improvement from baseline in NEI-VFQ-25 was +6.11 (11.46); corresponding improvements in near/distant activities were 11.37 (18.01)/7.33 (17.32). Mean (SD) change in BCVA at Week 52 was +10.0 (8.0) ETDRS letters. Mean (SD) change in CRT at Week 52 was –175.38 (132.62) μm. 53.6% patients had treatment-emergent adverse events (TEAEs), of whom 26.8% had an ocular TEAE in the study eye. Five (0.9%) serious adverse events led to death but were not considered treatment related. Overall, IVT-AFL was associated with improvements in NEI-VFQ-25 total score over 52 weeks, which was more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of IVT-AFL.