Three-year follow-up after fluocinolone acetonide implant injected one month after dexamethasone implant for treating diabetic macular edema: the ILUVI1MOIS Study

Introduction: The aim of this multicenter study was to assess the efficacy and safety of injecting a fluocinolone acetonide implant (FACi) one month after the last dexamethasone implant (DEXi) intravitreal injection (IVI) in chronic diabetic macular edema (DME) patients, as a Methods: This retrospective study evaluated a standardised care protocol implemented across five centres. Inclusion criteria were: pseudophakic, chronic DME treated with DEXi every <6 months, FACi injected one month after the last DEXi. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) and additional treatment were assessed on the day of FACi injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months until month 36 (M36). Results: Thirty-seven eyes (30 patients) were included: the median age was 73 [IQR: 66, 78] years and the median DME duration was 72 [59, 84] months. The mean BCVA was 62.8 ±17.7 letters at M0 and remained stable throughout the follow-up. The cumulative incidence of additional IVI was 35.1% [95%CI: 20.2; 50.5] at M12 and 70.1% [51.3; 82.8] at M36. Among the 25 eyes with additional IVI, the median reinjection interval increased by a factor of 4.3 [2.2; 8.4]. The mean IOP was 15.8 ±4.1 mmHg at M0 and remained stable during the follow-up. The cumulative incidence of the “IOP >30 mmHg” event was 2.7% [0.0; 12.2] at M12 and 18.8% [7.2; 34.4] at M36. One patient underwent incisional surgery (Xen Stent implantation). Conclusion: Injecting FACi one month after the last DEXi in patients requiring DEXi IVI every <6 months allowed maintaining the BCVA while spacing out or even discontinuing IVI with limited IOP concerns.