Abstract
PURPOSE: To compare the efficacy and safety between a first and a second injection of fluocinolone acetonide implants (FAc-I) in the treatment of diabetic macular oedema (DMO). METHODS: This retrospective, multicentre cohort study included eyes with chronic DMO that received two consecutive FAc-I injections. We analysed visual and anatomical outcomes, additional DMO treatments, and intraocular pressure (IOP)-related adverse events. RESULTS: We included 61 eyes from 44 patients. Stable or improved BCVA was observed in 100% of eyes after the first injection and in 93% after the second, demonstrating statistical equivalence within a ±15% margin (p = 0.005). Statistical equivalence was also found for the lowest CRT (±10% margin, p < 0.001) and for the proportion of eyes with ≥20% CRT decrease (±20% margin, p = 0.026). The proportion of patients requiring additional treatments during the first year was equivalent between injections (p = 0.036), with a therapeutic burden reduction of 63% and 59%, respectively. Regarding peak IOP, equivalence was observed between the two injections (±5 mmHg margin, p < 0.001). The incidence of OHT was numerically higher after the second injection (19.7% vs 11.5%, p = 0.302), but this difference was not statistically significant. CONCLUSION: Multiple FAc-I injections are a safe and effective treatment option for chronic DMO in real life. The second injection maintained similar functional and anatomical outcomes to the first, supporting the sustainability and repeatability of the treatment.