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

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.