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Case Reports
. 2021 Jul 7:15:2935-2943.
doi: 10.2147/OPTH.S283561. eCollection 2021.

Real-World Outcomes in Diabetic Macular Edema for the 0.2 µg/Day Fluocinolone Acetonide Implant: Case Series from the Midlands, UK

Bushra Mushtaq  1 , Ajay Bhatnagar  2 , Helen Palmer  3
Affiliations
Case Reports

Real-World Outcomes in Diabetic Macular Edema for the 0.2 µg/Day Fluocinolone Acetonide Implant: Case Series from the Midlands, UK

Bushra Mushtaq et al. Clin Ophthalmol. .

Abstract

Aim: To investigate real-world effectiveness and safety of fluocinolone acetonide (FAc) implant over three years of treatment in eyes with diabetic macular edema (DME) in a population with large ethnic diversity.

Methods: This audit of three large treatment centres in the UK involved retrospective collection of outcome data (best recorded visual acuity [BRVA] by Early Treatment Diabetic Retinopathy Study [ETDRS] letters, central retinal thickness [CRT], intraocular pressure [IOP] and use of supplementary treatments) from patients with DME treated with 0.2 µg/day FAc intravitreal implant with three-year follow-up expected.

Results: A total of 96 eyes were included. Ninety (93.8%) eyes had received prior intravitreal treatment. Increases in mean BRVA were significant at one, two and three years (p<0.05). Overall, 78.1% of eyes gained or maintained BRVA; just over 50% gained ≥5 letters, representing a functional response. Eleven (11.6%) patients lost ≥10 letters by year three. Decreases in central retinal thickness (CRT) nearing 200 µm in the first year were sustained to three years (p < 0.0001). Patients with baseline VA ≥60 letters maintained their BRVA throughout follow-up, while significant improvements at month 12 (p<0.0001) in those with baseline BRVA <60 letters were maintained through month 36 (p < 0.005). Fifty-three (55.2%) eyes required no supplementary therapy during follow-up. Increases in IOP to ≥30 mmHg and ≥25 mmHg were seen in 12 (12.5%) and 23 (24.0%) eyes, respectively.

Conclusion: This study confirms the effectiveness and tolerability of FAc implant up to 36 months in a real-world setting, highlighting the importance of early treatment for sustaining functional vision for patients.

Keywords: DME; case series; diabetic macular edema; fluocinolone acetonide; observational; real-world.

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Conflict of interest statement

Miss Bushra Mushtaq reports grants and personal fees from Novartis and consultant advisory board and travel grants from Bayer and Alimera Sciences, outside the submitted work. Miss Helen Palmer reports non-financial support from Alimera Sciences during the conduct of the study. The authors reported no other potential conflicts of interest for this work.

Figures

Figure 1
Figure 1
Mean BRVA (A) and CRT (B) at baseline, one, two and three years’ follow-up in 96 eyes after FAc implantation.
Figure 2
Figure 2
Mean BRVA and CRT at baseline, one, two and three years’ follow-up after FAc implantation in eyes that responded anatomically (increase of ≥20% EDTRS letters).
Figure 3
Figure 3
Mean BRVA (EDTRS letters) at baseline, one, two and three years’ follow-up after FAc implantation in eyes with BRVA <60 letters and ≥60 letters at baseline.
Figure 4
Figure 4
Box and whisker plot comparing mean change in BRVA (EDTRS letters) at three years’ follow-up for eyes with BRVA <60 letters and ≥60 letters at baseline. Values shown include the median (centre box line), the 25th and 75th interquartile ranges (box) and maximum and minimum values (whisker bars).
See this image and copyright information in PMC

References

    1. Sivaprasad S, Gupta B, Gulliford MC, et al. Ethnic variations in the prevalence of diabetic retinopathy in people with diabetes attending screening in the United Kingdom (drive uk). PLoS One. 2012;7(3):e32182–e82. doi:10.1371/journal.pone.0032182 - DOI - PMC - PubMed
    1. Wells JA, Glassman AR, Ayala AR, et al.; Diabetic Retinopathy Clinical Research N. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193–1203. doi:10.1056/NEJMoa1414264 - DOI - PMC - PubMed
    1. Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125–2132. doi:10.1016/j.ophtha.2012.04.030 - DOI - PubMed
    1. Boyer DS, Yoon YH, Belfort R Jr, et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121(10):1904–1914. doi:10.1016/j.ophtha.2014.04.024 - DOI - PubMed
    1. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the management of diabetic macular edema by the European society of retina specialists (euretina). Ophthalmologica. 2017;237(4):185–222. doi:10.1159/000458539 - DOI - PubMed

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