Abstract
Purpose :
The Retro-IDEAL study was conducted in Germany between September 2016 and November 2017, and aimed to assess real-world outcomes after 3 years of therapy with the FAc implant. The final results from all patients treated in this study are reported.To assess the effectiveness and safety of the FAc implant after three years.
Methods :
76 ILUVIEN treated patients (94 eyes) from 16 centres in Germany were involved retrospectively. Diabetic macular edema was the primary condition treated (n=82) but others also treated included cystoid macular edema (n=6), retinal vein occlusion (n=1) and uveitis (n=5). Patients were included if they had a suboptimal response to a first-line intravitreal therapy (in the majority of cases [96.8% or 91/94 eyes] a prior intravitreal injection was administered and in 81.3% of eyes, 4.2 injections of ranibizumab were administered in the 12 months prior to ILUVIEN). Of those included, 74.5% (70 eyes) had a pseudophakic and 48.9% (46 eyes) had been vitrectomized before ILUVIEN was injected. Patients were monitored up to month 36 (the mean follow-up period following ILUVIEN therapy was 30.8±11.3 months [±standard deviation]). Parameters measured included visual acuity (BCVA; reported as an ETDRS letter score), central macular thickness (CMT; µm) and intraocular pressure (IOP; mmHg).
Results :
Patients’ mean age was 66.9±12.2 years. At month 36 BCVA improved by 5.1 letters from a baseline of 49.8±17.4 letters. CMT improved by 184 µm from a baseline of 507 µm (see Figure) with 65.9% of eyes achieving a dry macula (i.e. <300 µm) throughout month 30. 12.8% (12/94 eyes) reached an IOP value of ≥30 mmHg and in 20.2% (19/94 eyes) IOP changed by ≥10 mmHg from baseline levels. 19% (18/94 eyes) required topical therapy. 2.1% (2/94 eyes) required surgery to manage elevated IOP.
Conclusions :
Despite substantial amounts of prior intravitreal treatments with anti-VEGF drugs and other therapies, the Retro-IDEAL study showed that sustained structural and functional improvements can be achieved up to 36 months with a single ILUVIEN implant.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.