Serrar Yasmine, Sejournet Lucas, Thomeret Victor, Dot Corinne, Bonnin Sophie, Soler Vincent, Rosier Laurence, Matonti Frédéric, Ghazaryan Mariam, Mathis Thibaud, Kodjikian Laurent
Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
UMR-CNRS 5510 Matéis, Université Lyon 1, Villeurbanne, France.
Eye (Lond). 2025 Jul 21. doi: 10.1038/s41433-025-03929-5.
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).
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.
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.
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.
比较首次与再次注射曲安奈德植入剂（FAc-I）治疗糖尿病性黄斑水肿（DMO）的疗效和安全性。
这项回顾性、多中心队列研究纳入了接受连续两次FAc-I注射的慢性DMO患者的眼睛。我们分析了视力和解剖学结果、额外的DMO治疗以及与眼压（IOP）相关的不良事件。
我们纳入了44例患者的61只眼睛。首次注射后100%的眼睛最佳矫正视力（BCVA）稳定或改善，再次注射后为93%，在±15%的 margin 内显示出统计学等效性（p = 0.005）。在最低中央视网膜厚度（CRT）（±10% margin，p < 0.001）以及CRT降低≥20%的眼睛比例（±20% margin，p = 0.026）方面也发现了统计学等效性。第一年需要额外治疗的患者比例在两次注射之间相当（p = 0.036），治疗负担分别降低了63%和59%。关于眼压峰值，两次注射之间观察到等效性（±5 mmHg margin，p < 0.001）。高眼压（OHT）的发生率在再次注射后在数值上更高（19.7%对11.5%，p = 0.302），但这种差异无统计学意义。
多次注射FAc-I是现实生活中慢性DMO的一种安全有效的治疗选择。再次注射维持了与首次相似的功能和解剖学结果，支持了该治疗的可持续性和可重复性。
