Background The ILUVIEN Registry Safety Study was a multicentre, open-label, non-randomised, observational, phase 4 study designed to assess the safety and effectiveness of the fluocinolone acetonide (FAc) implant in all indications in real-world practices in Europe. Methods The study included data collected prospectively and retrospectively. Patients receiving FAc implants between 2013 and 2017 were included and monitored until the last patient reached ≥3 years of follow-up. Mean intraocular pressure (IOP) data over the course of the study, along with IOP events, use of IOP-lowering therapy, mean change in visual acuity (VA) and information on supplemental therapy use were analysed post-FAc implantation. Results Six hundred and ninety-five eyes from 556 patients, with a mean±SD follow-up of 1150.5±357.36 days, were treated with a FAc implant. 96.7% of eyes had chronic diabetic macular oedema (cDMO). IOP lowering was achieved in 34.5% of eyes using topical agents and 4.3% by surgery. Seventy-three eyes (64.6% of 113 phakic) required cataract surgery during follow-up. Mean VA increased from a baseline of 52.2 letters to 57.1 letters at month 36, with improvement observed up to month 48. Supplementary therapies were given in 43.7% of eyes. When classified by length of cDMO less than or greater than the median duration those with a shorter history experienced greater VA gains than those with a longer history. Conclusion This study confirms the favourable, long-term benefit-to-risk profile of the FAc implant in eyes with cDMO, with an additional benefit in patients when this therapy is administered earlier.

中文翻译：

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氟轻松丙酮玻璃体内植入物 (ILUVIEN) 的安全性和有效性：欧洲 IRISS 注册研究的 3 年结果

背景 ILUVIEN 注册安全研究是一项多中心、开放标签、非随机、观察性 4 期研究，旨在评估氟轻松 (FAc) 植入剂在欧洲实际实践中所有适应症的安全性和有效性。方法 该研究包括前瞻性和回顾性收集的数据。纳入并监测 2013 年至 2017 年间接受 FAc 植入的患者，直至最后一名患者达到 ≥ 3 年的随访。FAc 植入后，对研究过程中的平均眼压 (IOP) 数据以及 IOP 事件、降眼压治疗的使用、视力 (VA) 的平均变化以及补充治疗使用的信息进行了分析。结果 556 名患者的 695 只眼睛接受了 FAc 植入物治疗，平均±SD 随访时间为 1150.5±357.36 天。96.7% 的眼睛患有慢性糖尿病性黄斑水肿 (cDMO)。34.5% 的眼睛使用局部药物实现了眼压降低，4.3% 的眼睛通过手术实现了眼压降低。随访期间，73 只眼睛（113 只有晶状体眼患者中的 64.6%）需要进行白内障手术。平均 VA 从基线 52.2 个字母增加到第 36 个月时的 57.1 个字母，并在第 48 个月观察到改善。43.7% 的眼睛接受了补充治疗。当按照小于或大于中位持续时间的 cDMO 长度进行分类时，历史较短的人比历史较长的人经历了更大的 VA 增益。结论 这项研究证实了 FAc 植入物在 cDMO 眼中具有良好的长期获益风险比，并且早期进行这种治疗会给患者带来额外的益处。