title: Report of 12-months efficacy and safety of intravitreal fluocinolone acetonide implant for the treatment of chronic diabetic macular oedema: a real-world result in the United Kingdom.
abstract: PurposeTo report the 12-months visual and anatomical outcomes of chronic diabetic macular oedema (DMO) treated with ILUVIEN in a real-world clinical practice in a single tertiary referral centre.MethodRetrospective data collection and analysis of consecutive 28 eyes of 23 diabetic patients received ILUVIEN implant for refractory DMO. Standard assessment included visual acuity (VA), central retinal thickness (CRT), slit-lamp biomicroscopy, and Goldmann tonometry for intraocular pressure (IOP) at 1, 6, and 12 months.ResultsBaseline mean VA was 47 (SD 18) letters improved to 55 (SD 17) letters (P=0.004) at 12 months. VA was improved in 16 eyes (57%), stabilised in 9 eyes (32%), and decreased in 3 eyes (11%). Seven eyes (25%) gained ≥15 letters, and 10 eyes (36%) gained >10 letters from baseline. The percentage of eyes achieved driving vision (≥70 Early Treatment Diabetic Retinopathy Study letters) was doubled from baseline 18 to 36% at 6 months and 32% at 12 months. Mean CRT decreased by 198 μm from baseline 494 μm (SD 191) to 296 μm (SD 121) at 12 months (P<0.001). Two eyes received additional anti-vascular endothelial growth factor injections after 10 months.
  
  
  RESULTS
  Raised IOP in three eyes (11%) controlled with IOP-lowering drops, vitreous haemorrhage in one eye and one endophthalmitis (1 year vision improved to 6/24).ConclusionOur real-world results show that the visual and the anatomical improvements achieved by a single ILUVIEN implant injection were maintained up to 12 months with minimal adjunctive therapy. IOP monitoring remains essential in ILUVIEN patients, although our study shows a relatively low risk of IOP elevation post ILUVIEN injection, even in existing controlled ocular hypertension. Our results demonstrate that ILUVIEN is an effective long-term option in treating chronic refractory DMO.
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: F
authors.initials: F
authors.lastname: Alfaqawi
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: P L
authors.initials: PL
authors.lastname: Lip
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: S
authors.initials: S
authors.lastname: Elsherbiny
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: R
authors.initials: R
authors.lastname: Chavan
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: A
authors.initials: A
authors.lastname: Mitra
authors.affiliation: Department of Ophthalmology, Birmingham and Midland Eye Centre, City Hospital, Birmingham, West Midlands, UK.
authors.forename: B
authors.initials: B
authors.lastname: Mushtaq
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008269:Macular Edema / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D014792:Visual Acuity
chemical_list: D005938:Glucocorticoids; D005446:Fluocinolone Acetonide