Three-Year Follow-Up after Fluocinolone Acetonide Implant Injected 1 Month after Dexamethasone Implant for Treating Diabetic Macular Edema: The ILUVI1MOIS Study

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INTRODUCTION: The aim of this multicenter study was to assess the efficacy and safety of injecting a fluocinolone acetonide implant (FACi) 1 month after the last dexamethasone implant (DEXi) intravitreal injection (IVI) in chronic diabetic macular edema (DME) patients. METHODS: This retrospective study evaluated a standardized care protocol implemented across 5 centers. Inclusion criteria were as follows: pseudophakic, chronic DME treated with DEXi every <6 months, FACi injected 1 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 (interquartile range [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 mm Hg at M0 and remained stable during the follow-up. The cumulative incidence of the "IOP >30 mm Hg" 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 1 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.

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