Evaluation of the clinical effectiveness in routine practice of the fluocinolone acetonide intravitreal implant in patients with diabetic macular oedema

Session Details

Session Title: Free Paper Session 7: Vascular Diseases & Diabetic Retinopathy II

Session Date/Time: Thursday 07/09/2017 | 14:30-16:00

Paper Time: 14:48

Venue: Room 117

First Author: : C.Currie UK

Co Author(s): :    S. Holden   D. Owens                          

Abstract Details

Purpose:

The aim of the ILUVIEN Clinical Evidence study in the United Kingdom (ICE-UK) was to assess clinical outcomes and characterise the long-term effect of the fluocinolone acetonide (FAc) intravitreal implant in routine clinical practice. We aimed to evaluate the effectiveness of the FAc implant in patients with diabetic macular oedema (DMO) in terms of preventing further vision loss or improving vision and to characterise changes in central foveal thickness (CFT) and intraocular pressure (IOP).

Setting:

A retrospective study was conducted. Patients with DMO treated with FAc at any of 13 participating ophthalmology centres in the UK were included.

Methods:

Patients were included in the cohort if they had received an FAc 190 µg intravitreal implant in at least one eye at a participating site between 1 April 2013 and 15 April 2015 and had a minimum of 12 months’ history prior to implant. The end of the observation period was 15 April 2016. Patients receiving FAc intravitreal implant in both eyes were allowed to contribute both eyes to the study. Data were collected for 365 days prior to and at least 365 days post FAc implant from patients’ medical records. Visual acuity (VA), CFT and IOP were compared between implant and 12 months using the Wilcoxon signed ranks test. Missing values were imputed using last observation carried forward. Analyses were conducted overall and by subgroup based on the number of treatments for DMO prior to implant (1–6 treatments and >6 treatments).

Results:

208 patients contributing 233 eyes treated with FAc implant were included. Mean age was 68.1 years, 62% were male and 89% of treated eyes were pseudophakic. 223 (96%), 173 (74%) and 181 (78%) treated eyes had a VA, CFT and IOP measurement recorded both prior to implant and in the 12 month period post implant, respectively. A decrease in VA was observed between day -365 and date of FAc implant. 44%, 30% and 18% of patients achieved an improvement in Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥5, ≥10 and ≥15 letters, respectively between implant and 12 months post implant. Over the same period median (interquartile range, IQR) VA improved from 0.66 (0.50–1.00) LogMAR units to 0.60 (0.40–0.86) LogMAR units at 12 months (p<0.001). Median (IQR) CFT decreased from 462 µm (354–603 µm) at implant to 309 µm (222–433 µm) at 12 months post implant (p<0.001). Over the same period, a reduction of ≥10%, ≥25% and ≥50% in CFT was observed in 113 (65%), 87 (50%) and 37 (21%) treated eyes, respectively. Median (IQR) IOP was 15.0 (13.0–18.0) mmHg at implant and 18.0 (15.0–21.0) mmHg at 12 months (p<0.001).

Conclusions:

An overall improvement in visual acuity and marked reduction in central foveal thickness was observed in the 12 months following fluocinolone acetonide intravitreal implant. Visual acuity improved by at least 15 letters in nearly one fifth of treated eyes at 12 months post implant. A small but statistically significant increase in intraocular pressure was also recorded.

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