Abstract
Purpose :
The European licence requires that for the 0.19 mg fluocinolone implant (FAc) treatment, patients should have vision impairment associated with chronic diabetic macular edema (DME). To date, no consensus has been achieved defining chronic DME. To determine if some eyes had an expanded benefit-to-risk ratio, the effect of duration of DME on visual and anatomic outcomes following FAc implant, was explored by our group.
Methods :
This is a retrospective, comparative analysis of 35 eyes diagnosed with DME and treated with FAc implant due to insufficient response to first line therapies. In this analysis, eyes were divided into 2 groups: 17 eyes with a DME diagnosis >3 years (group 1) and 18 eyes with a DME diagnosis ≤ 3 years (group 2). Outcome measures included mean changes in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters, central foveal thickness (CFT), and intraocular pressure (IOP). These outcomes were measured prior to administration of the FAc implant, at month 1, and quarterly thereafter post-FAc implant. The mean follow-up (mean±standard deviation) for group 1 and group 2 was 29.3±6.5 months and 28.1±6.4 months, respectively (p=0.668). Prior DME therapies included laser (100% of cases) and intravitreal injections (100%).
Results :
Following the FAc implant, the mean change in VA at the last observation, from baseline, was +12.1 letters in group 1 and +16.8± 25.9 letters in group 2 (p=0.201). From baseline, a gain of ≥ 15 letters were achieved in 37.5% and 52.9% of the eyes in group 1 and group 2, respectively. Additionally, an improvement in vision ≥ 70 ETDRS letters in 18.8% of group 1 and 35.3% of group 2 was observed. The mean change in CFT was -182.9 μm and -232.4 μm in group 1 and group 2, respectively (p=0.448). The mean change in IOP was +0.62 mmHg in group 1 and +0.58 mmHg in group 2, relative to baseline. At the last observation point, there were no significant differences between groups 1 and 2 (p> 0.05) in terms of their changes in VA, CFT, and IOP.
Conclusions :
The current findings are in line with the preliminary results of the ILUVIEN Registry Safety Study andand demonstrates the clinically meaningful effectiveness of the FAc implant. This analysis highlights the benefits of early treatment of DME with the FAc implant in terms of VA, CFT and IOP.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.