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. 2019 Dec 15;4(1):e000405.
doi: 10.1136/bmjophth-2019-000405. eCollection 2019.

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

Dilraj S Grewal  1 , Donald C Fletcher  2   3 , Seenu M Hariprasad  4 , Ivan J Suner  5
Affiliations

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

Dilraj S Grewal et al. BMJ Open Ophthalmol. .

Abstract

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.

Keywords: Retina.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Mean NEI-VFQ-25 DSS score over time for all patients (mean±SE). Baseline DSS: quartile 1, 0–25; quartile 2, >25–50; quartile 3, >50–75; quartile 4, >75–100. DSS, driving subscale; FAc, fluocinolone acetonide; mo, months; NEI-VFQ-25, National Eye Institute Visual Functioning Questionnaire-25.
Figure 2
Figure 2
Mean change in driving subscale (DSS) score over 3 years by baseline DSS quartile (±SE). FAc, fluocinolone acetonide.
Figure 3
Figure 3
Percentage of patients achieving best-corrected visual acuity (BCVA) of 20/40 or better over time, by baseline NEI-VFQ-25 driving subscale score quartile. FAc, fluocinolone acetonide; mo, months; NEI-VFQ-25, National Eye Institute Visual functioning Questionnaire-25.
Figure 4
Figure 4
Control of oedema over 36 months by baseline driving subscale (DSS) score quartile. AUC, area under the curve; CST, central subfield thickness; FAc, fluocinolone acetonide.
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References

    1. Wang Y, Alnwisi S, Ke M. The impact of mild, moderate, and severe visual field loss in glaucoma on patients' quality of life measured via the glaucoma quality of Life-15 questionnaire: a meta-analysis. Medicine 2017;96:e8019 10.1097/MD.0000000000008019 - DOI - PMC - PubMed
    1. Garcia GA, Khoshnevis M, Gale J, et al. . Profound vision loss impairs psychological well-being in young and middle-aged individuals. Clin Ophthalmol 2017;11:417–27. 10.2147/OPTH.S113414 - DOI - PMC - PubMed
    1. Hariprasad SM, Mieler WF, Grassi M, et al. . Vision-related quality of life in patients with diabetic macular oedema. Br J Ophthalmol 2008;92:89–92. 10.1136/bjo.2007.122416 - DOI - PubMed
    1. Gabrielian A, Hariprasad SM, Jager RD, et al. . The utility of visual function questionnaire in the assessment of the impact of diabetic retinopathy on vision-related quality of life. Eye 2010;24:29–35. 10.1038/eye.2009.56 - DOI - PubMed
    1. Suñer IJ, Bressler NM, Varma R, et al. . Responsiveness of the National eye Institute visual function questionnaire-25 to visual acuity gains in patients with diabetic macular edema: evidence from the ride and rise trials. Retina 2017;37:1126–33. 10.1097/IAE.0000000000001316 - DOI - PMC - PubMed

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