Fluocinolone acetonide implant in diabetic macular edema: sustained benefits and effects of following prior therapy

Abstract Purpose To (1) evaluate long-term real-world anatomical and functional outcomes after implantation of a sustained-release fluocinolone acetonide (FAc) implant in eyes with diabetic macular edema (DME) and (2) to assess the influence of prior anti–vascular endothelial growth factor (anti-VEGF) and corticosteroid exposure on treatment response and durability. Methods This retrospective, single-center study included 74 eyes from 47 DME patients treated with intravitreal FAc implant. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP), prior treatment burden, and need for additional intravitreal therapy were evaluated over a median follow-up of 40 months. Baseline changes were analysed using paired statistical testing. Spearman correlations assessed associations between prior treatment exposure and clinical outcomes. Results FAc implantation significantly reduced CRT (median −75.5 µm; p<0.001). Eyes receiving fewer than six prior anti-VEGF injections demonstrated greater CRT reduction (−93 µm; p<0.001) than eyes receiving six or more injections (−65 µm; p=0.015). BCVA improved modestly overall (+3.95 ETDRS letters; p=0.037), with greater gains in less pretreated eyes (+7.53 letters; p=0.002) compared to eyes with ≥6 prior injections (+0.0 letters; p=0.492). Higher prior anti-VEGF burden correlated with shorter treatment durability (ρ = −0.35; p<0.003) and increased need for supplemental therapy (ρ = 0.30; p<0.001). Conclusions FAc implantation provides sustained anatomical improvement and modest functional benefit in DME, particularly when introduced earlier in the treatment course. Earlier integration of long-acting corticosteroid therapy may enhance durability and reduce cumulative anti-VEGF burden.