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.
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Contributors DSG had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the acquisition, analysis or interpretation of data and critical revision of the manuscript for important intellectual content.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests DSG reports consultancy with Alimera Sciences and EyePoint Pharmaceuticals. SMH reports consultancy or speaker’s bureau membership with EyePoint Pharmaceuticals, Alimera Sciences, Ocular Therapeutix, Alcon, Allergan, OD-OS, Sandoz-Novartis, Spark Therapeutics, Regeneron and Clearside Biomedical. IJS reports consultancy or speaker’s bureau membership with Alimera Sciences, Allergan, Genentech, Novartis and Regeneron.
Patient consent for publication Not required.
Ethics approval The protocol was approved by the institutional review board/ethics committee at each study site, and the trials were conducted in accordance with the Declaration of Helsinki. All patients provided written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request.
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