Efficacy and Safety of Fluocinolone Acetonide Implant (Iluvien®) in Postoperative Cystoid Macular Edema: ILUCYD study

Abstract

Purpose : Postoperative cystoid macular edema (PCME) is a common complication after vitreoretinal and cataract surgery with chronic or recurrent cases posing a significant therapeutic challenge. The aim of this study was to report the efficacy and safety of sustained-release fluocinolone acetonide (FAc) 0.19 mg intravitreal implant (Iluvien ®) in the treatment of chronic PCME.

Methods : A retrospective multicentric study was conducted in a real-world setting in tertiary care centers in France. Eyes with chronic PCME after cataract or either multiple or single vitreoretinal surgeries, previously treated with multiple injections of intravitreal dexamethasone (DEX) implant (Ozurdex®), and then treated with FAc-implant were included. Best corrected visual acuity (BCVA) and central retinal thickness (CRT) were assessed as primary endpoints over the follow-up of 12 months. Main secondary endpoints included increase in intraocular pressure (IOP) and other adverse events, proportion of patients maintaining BCVA of at least 20/40, proportion of patients needing additional non-study treatment and OCT-markers associated with better BCVA.

Results : 21 eyes from 21 patients were included. The mean baseline BCVA was 0.37 ± 0.23 logMAR and increased to 0.25 ± 0.18 logMAR at month 12 (p=0.0008). The mean baseline CRT was 425.9 ± 133.6 µm and decreased to 316.9 ± 67.0 µm by month 12 (p=0.0002). The mean IOP was 13.2 ± 3.7 mmHg at baseline and 14.73 ± 4.45 mmHg at month 12 (p=0.22). The proportion of eyes with BCVA of at least 20/40 increased from 52% at baseline to 82% at month 12 (p=0.007). At 3 months the odds of reaching BCVA ≥ 20/40 were higher in eyes with intact external limiting membrane. An additional therapy with DEX-implant was delivered in 8 eyes (38.1%). The number of the DEX-implant per year was lower after FAc implantation (mean of 1.5 ± 0.5 DEX-implant/year) compared to the year preceding FAc implantation (mean of 3.05 ± 1.65; p=0.001).

Conclusions : FAc implant in eyes with chronic PCME showed lasting anatomic and functional improvement with a good safety profile. Final BCVA was correlated with intact outer retinal layers on SD-OCT. Furthermore, FAc implant allowed reduction of the treatment burden over 12 months.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.