Abstract
Purpose :
In contrast to the Retro-IDEAL study, the IDEAL registry study is a prospective non-interventional study with a target of recruiting 350 patients with persistent or recurrent DME despite treatment. The long-term objective of this study is to assess the effectiveness and tolerability of the fluocinolone acetonide (FAc; ILUVIEN) implant in real-world practices in Germany and here we report the interim analysis results.
Methods :
So far, a total of 118 eyes from 105 patients with DME have been recruited from nineteen clinical practices and monitored for up to 27 months in this ongoing clinical study. Patients had persistent or recurrent DME (duration of 51.88±37.03 months) (mean±SD) and switched to the FAc implant after suboptimally responding to prior laser (82.05% of eyes) and intravitreal treatments (99.15%; range of injections between 1 and 4). The mean age of patients was 66.52±8.95 (range, 42-88 years) and they mainly had type II diabetes (n=109). Parameters measured included best-corrected visual acuity (BCVA), central macular thickness (CMT) and intraocular pressure (IOP).
Results :
At baseline CMT was 408.72±156.45 microns (n=111) and had decreased to 317.69±152.25 (n=44) and 330.14±79.40 microns (n=7) at 12 and 24 months, respectively. The percentage of patients achieving a CMT less than 300 microns was 28.83% at baseline and increased to 57.00% at last observation. Baseline visual acuity was 57.59±17.86 letters (n=117) and remained stable at month 12 (56.06±17.51 letters) and month 24 (56.25±18.05 letters). IOP remained stable throughout, increasing slightly from 15.31±3.30 mmHg at baseline (n=111) to 16.14±4.84 mmHg (n=12) at month 24. Only 22.03% of eyes were treated with IOP lowering eye drops during the follow-up period. No eye required IOP-lowering surgery.
Conclusions :
The current analysis of patients with persistent or recurrent DME (i.e. long duration of DME and extensive prior therapies) shows that the FAc implant led to marked structural improvements in CMT. This was associated with the stabilisation of BCVA and a manageable side effect profile where IOP was controlled with IOP lowering eye drops alone.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.