Early adoption of the fluocinolone acetonide (FAc) intravitreal implant in patients with persistent or recurrent diabetic macular edema (DME)

Jessica D McCluskey, Paul L Kaufman, Kathy Wynne, Gregory LewisDepartment of Ophthalmology, Thomas Eye Group, Atlanta, GA, USAObjective: To assess long-term outcomes for effectiveness, safety, and treatment burden after injection of 0.2 μg/day fluocinolone acetonide [FAc] intravitreal implant (ILUVIEN®) in patients with persistent or recurrent diabetic macular edema (DME) and 6–18 months of follow-up.Methods: Retrospective case series in 18 eyes (13 patients) treated with the FAc implant. Prior to the implant, eyes were treated with an anti-VEGF therapy, dexamethasone implant, or focal or panretinal photocoagulation. Effectiveness outcomes included changes in visual acuity and macular edema. Safety outcomes included intraocular pressure (IOP) changes, IOP drugs, and IOP-related surgeries/interventions. Treatment burden was assessed by comparing the number of DME treatments before and after FAc implantation.Results: The FAc implant reduced macular volume in 16/18 (89%) eyes, with a statistically significant mean change of –1.33 mm3 (p=0.001). The average central retinal thickness reduction for all 18 eyes was statistically significant, decreasing from 444 μm at baseline to 359 μm after the FAc implant (p<0.001). In 90% of eyes, visual acuity was stable throughout the follow-up period, with increases or no worsening in Early Treatment Diabetic Retinopathy Study letter score. Although mean IOP was statistically higher after treatment, it was within the normal range at all timepoints, and most (83.3%) eyes remained in the IOP category 0–22 mmHg, and the number of IOP treatments required did not increase and no patients required IOP-lowering surgery. Treatment burden for DME was reduced after the implant was administered, with 56% of eyes not requiring any additional treatment. The average number of treatments was 1.3 in the 6 months after the FAc implant versus 4.6 in the 12 months preceding the implant.Conclusion: The FAc implant is an appropriate option to incorporate earlier in the DME treatment process, leading to positive long-term outcomes with an acceptable safety profile, and a reduced treatment burden for patients, and reduced clinical staff time.Keywords: persistent diabetic macular edema, recurrent diabetic macular edema, DME, visual acuity, macular volume, fluocinolone acetonide implan