Effect of fluocinolone acetonide 0.2 μg/day implant on the decision to drive in patients with diabetic macular oedema: a report from the FAME study

OBJECTIVE: This study aimed to determine whether treatment with the 0.2 µg/day fluocinolone acetone implant (FAc; ILUVIEN, Alimera Sciences) and the associated improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) demonstrated in the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study have an impact on the patient’s decision to drive as measured by the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25). METHODS: This was a post hoc analysis of up to 3 years of NEI-VFQ-25 data collected during the phase III FAME trial. Patients were divided into four quartiles according to baseline NEI-VFQ-25 driving subscale (DSS) score. Patients who had never driven were excluded. Patients received either the 0.2 µg/day FAc implant or sham (dummy injection). Change in the DSS score of the NEI-VFQ-25 questionnaire over 3 years in FAc-treated versus sham-treated patients was analysed by BCVA, CST and baseline DSS score. RESULTS: The proportion of patients achieving BCVA≥20/40 was similar between the FAc and sham groups throughout the study, while improvements in CST were significantly greater in the quartile of FAc-treated patients with the lowest baseline DSS score (quartile 1; p=0.04). Significant improvements in DSS score were also observed in quartile 1 (p=0.024), while numerical—but not significant—improvements in DSS score were observed in the full cohort. CONCLUSION: This post hoc analysis demonstrates a significant association between clinical outcomes in diabetic macular oedema and improvement in quality of life measures following a single FAc implant.