First Author: C.Currie UK
Co Author(s): S. Holden D. Owens
Back to previous
The purpose of the Iluvien® Clinical Evidence study in the UK (ICE-UK) was to assess the real-world effectiveness of fluocinolone acetonide (FAc) intravitreal implant for the treatment of diabetic macular oedema (DMO) in routine clinical practice. Visual acuity, central foveal thickness (CFT) and intraocular pressure (IOP) were compared between eyes treated with the FAc implant (study eye) and the fellow eye not treated with FAc implant.
This was a retrospective observational study of patients with DMO treated with FAc intravitreal implant at any of 13 participating ophthalmology centres in the UK.
Patients were selected if they received an FAc implant for the treatment of DMO in at least one eye between 1 April 2013 and 15 April 2015 and had at least 12 months’ history prior to implant. Data were collected before and after FAc implant from patients’ medical records. Patients were censored on the date of insertion of a second FAc implant in the fellow eye where this occurred. Changes in visual acuity, CFT and IOP were compared between study and fellow eyes using the paired t-test. The proportion of patients achieving an increase in letter score between implant and 12 months was compared between study and fellow eyes using McNemar’s test. Last observation carried forward was used to impute missing values.
208 patients were selected. Mean age was 68.1 years and 62% were male. At 12 months post implant, 180 patients had been treated with FAc intravitreal implant in the study eye only. 38 patients were treated bilaterally with FAc implant and were censored before the end of the 12 months follow-up. Mean change in visual acuity was significantly different in study eyes and fellow eyes at 12 months post-implant (-0.09 Logarithm of the Minimum Angle of Resolution [LogMAR] units versus 0.04 LogMAR units, respectively, p<0.001, n=158). Over the same period, an improvement of ≥5 letters, ≥10 letters and ≥15 letters in ETDRS score was achieved by more study eyes than by fellow eyes (41% versus 23%, p<0.001, 28% versus 11%, p<0.001, and 18% versus 4%, p<0.001, at 12 months, respectively). A difference in the mean change in CFT (-113µm versus -13µm, p<0.001, n=114) and IOP (3.2 mmHg versus -0.2 mmHg, p<0.001, n=120) was also observed between study and fellow eyes at 12 months.
At the end of the 12 month follow-up period, a statistically significant improvement in visual acuity and central foveal thickness and a worsening in intraocular pressure were observed in eyes treated with fluocinolone acetonide intravitreal implant when compared with the patient’s fellow eye.