OSLI Retina

November 2020

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November 2020 · Vol. 51, No. 11 659 The impact of DME and treatment on patients' daily lives and wellbeing may be as important as the structural/functional outcomes (ie, CST and BCVA). Patient-reported outcomes and quality of life (QOL) measures represent valuable tools for the measure- ment of visual function-related treatment outcomes and enable management strategies to be developed to mitigate the impact of DME on patients' lives. Vision-related QOL measures (eg, social functioning and mental health) may also affect areas including treatment adherence/satisfaction. The high risk of non-adherence to treatment and follow-up appoint- ments, and consequent increased risk of a loss in vi- sual acuity (VA) and suboptimal treatment outcomes, has been documented. 9 The National Eye Institute Visual Functioning Ques- tionnaire-25 (NEI-VFQ-25), a health-related question- naire with 25 questions, quantifies the impact of vision on QOL. 10,11 Previous studies have used the NEI-VFQ-25 to evaluate QOL outcomes following DME therapies. 12 Results have shown intravitreal vascular endothelial growth factor (VEGF) inhibitors are associated with meaningful improvements in BCVA and NEI-VFQ-25 scores during a period of 1 year. 13-15 Previous explorato- ry analysis of the FAME study (NCT00344968) looking at driving subscale scores, measured using NEI-VFQ-25, concluded that these improvements were related to the better control of edema rather than central visual func- tion as assessed by BCVA. 16 Based on this previous work by Grewal et al., 12 the current exploratory post-hoc analysis of the Fluocinolone Acetonide in Diabetic Macular Ede- ma (FAME) dataset examined the relationship be- tween the control of DME provided by the 0.2 µg/ day fluocinolone acetonide (FAc; Iluvien, Alimera Sciences, Alpharetta, GA) implant, patient-reported QOL, and BCVA during the 3-year treatment period. In the U.S., the 0.2 µg/day FAc implant is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intra- ocular pressure. The implant provides continuous microdose delivery of FAc for 3 years; alternative therapies (eg, anti-VEGF) typically provide shorter- term control of edema requiring repeated injections every 4 to 8 weeks to treat DME. 1 The FAME study demonstrated that treatment with the 0.2 µg/day FAc implant in patients with DME provides a long- Figure 1. Overall National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25) score for all patients from baseline to Year 3. *P < .05; **P < .001; clinically meaningful change in NEI-VFQ-25 score shown by dashed line.

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