Clinical Effectiveness of Intravitreal Fluocinolone Acetonide (FAc) (ILUVIEN™) in Patients with Diabetic Macular Oedema (DMO) Refractory to Prior Therapy: The Manchester Experience.

introductionDiabetic macular oedema (DMO) remains a significant cause of sight loss in the UK. Despite macular laser and anti-VEGF agents, a large proportion of patients remain with persistent DMO. We present our results of using 0.19 mg fluocinolone acetonide (FAc) intravitreal implant in this cohort with up to 3 years of follow-up.

methodsThis is a single-centre retrospective review of patients treated with FAc implant for refractory DMO. The primary efficacy end point was visual acuity and secondary efficacy end point was central retinal thickness (CRT) on OCT. A primary safety end point was a rise in IOP requiring treatment.

resultsTwenty-one eyes were identified with an average follow-up of 27 months (6-36 months). Visual acuity change from baseline was - 0.1 ETDRS letters at year 1 (n = 13), 8.1 letters at year 2 (n = 13) and 10.7 letters at year 3 (n = 10). CRT improved by - 132.1 µm at year 1 (n = 15), - 172.8 µm at year 2 (n = 13) and - 157.8 µm at year 3 (n = 10). Five eyes (24%) required further anti-VEGF during follow-up and two (9.5%) required further focal laser. IOP rise requiring treatment was noted in eight eyes (38%). Seven were steroid induced. One was caused by rubeotic glaucoma. Six (75%) were managed medically and the remaining two also required surgery.

conclusionThis data add to the limited real-world data on FAc in DMO with 3 years of follow-up. Vision and macular architectures both improved at varying rates over 3 years in patients with refractory DMO. IOP rise is a risk but, in the majority, it can be managed medically.