Abstract
Purpose :
Clinical trials and previous case studies have shown the efficacy and safety of long-term use of the 0.19 mg FAc implant. This retrospective, cohort study of 48 eyes (42 patients) with diabetic macular edema (DME) was performed by a single practice in the greater Cleveland area (9 sites; 5 physicians) with a broad range of demographics and underlying disease severity. This case series assessed injection burden, foveal thickness, visual acuity, and changes in intraocular pressure (IOP) before and after treatment with FAc implant in a real-world setting.
Methods :
Eyes with DME treated with at least one FAc intravitreal implant, subsequent to a prior corticosteroid, and with at least one year of follow-up (mean, 18.1 ± 7.9 months) were included in this analysis. Data were collected on visual acuity (VA), central foveal thickness (CFT), intraocular pressure (IOP), and supplemental treatments after a single FAc implant
Results :
Mean age at the time of FAc administration was 67.7 ± 11.2 years. The mean baseline VA before implant was 59.6 ± 13.7 letters and remained stable (see table). Mean CFT before ILUVIEN was 392.7 ± 117.5 μm and showed a steady decline at 1 and 2 years (see table); 32.6% of eyes required no additional treatment. In patients receiving supplemental therapy, the treatment burden was reduced from 1 treatment every 1.9 months pre-FAc to 1 treatment every 5 months post-FAc. A mild, nonsignificant increase in IOP (see table) was observed throughout follow-up; 7 eyes experienced a rise in IOP (above 22 mmHg), and all were effectively managed with topical drops.
Conclusions :
This long-term study adds to the current body of literature on the safety and effectiveness of the FAc implant in US real-world practices. Findings showed that all patients experienced stable VA, reduced foveal thickness, and a reduction of injections post-FAc administration.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.