Abstract
Purpose :
To evaluate real-world clinical outcomes of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant in the treatment of patients with diabetic macular edema (DME)
Methods :
This is a retrospective analysis of anonymized data from patients treated with a single FAc intravitreal implant for the clinical indication of center-involving edema in a real-world patient population. Primary outcomes measured include changes in best-corrected visual acuity, central subfield thickness and frequency of DME-related treatments 12 months pre- and up to 36 months post-FAc administration. Changes in intraocular pressure (IOP), use of IOP-lowering medications/interventions and adverse events were also measured. IRB approval was obtained by coauthors and the study followed the tenets of the Declaration of Helsinki.
Results :
152 eyes of 117 patients were followed for 12.1 ± 4.1 and 28.6 ± 14.7 months pre- and post-FAc administration, respectively. A +2.1-letter increase in mean best-corrected visual acuity (BCVA) was observed at month 24 in comparison to baseline. The proportion of patients attaining a BCVA ≥ 70 ETDRS (20/40 Snellen equivalent) increased from 32.2% at baseline to 41.9% at month 24 post-FAc administration. Mean central subfield thickness (CST) decreased from 375.6 μm to 348.2 μm at month 24, and an overall 1.9-fold increase was seen in the proportion of patients attaining a CST ≤ 300 μm. Treatment burden was significantly reduced; Mean frequency of anti-VEGF intravitreal injections administered and/or laser photocoagulation performed decreased from 4.7 to 1.4 treatments per year post-FAc administration (p<0.0001). On average, supplemental DME-related treatments were administered at month 17 after implant delivery. IOP remained stable throughout follow-up, although a significant increase of +1.4 mmHg was observed at month 4. The incidence of an IOP increase ≥ 25 mmHg and ≥ 30 mmHg was 18.4% and 9.9%, respectively. IOP elevations above baseline were managed with IOP-lowering medication, although surgical intervention and IOP-lowering procedures were required.
Conclusions :
The 0.19-mg FAc intravitreal implant provided long-term stabilization of visual acuity and macular anatomy in the management of patients with center-involving DME, despite a significant reduction in treatment frequency.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.