OBJECTIVES: To examine vision-related quality of life in patients with diabetic macular edema treated with intravitreal aflibercept (IVT-AFL).

METHODS: 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.

RESULTS: CONCLUSIONS: 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.