International Vision Correction Research Centre, Department of Ophthalmology, University Hospital Heidelberg, Heidelberg, Germany.
Centre for Public Health, Blackwell's Queen's University, Belfast, UK.
Br J Ophthalmol. 2023 Oct;107(10):1502-1508. doi: 10.1136/bjo-2022-321415. Epub 2022 Jul 15.
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.
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.
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.
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.
ILUVIEN 注册安全研究是一项多中心、开放性、非随机、观察性的 4 期研究，旨在评估氟轻松（FAc）植入物在欧洲真实环境下的所有适应证中的安全性和有效性。
该研究包括前瞻性和回顾性收集的数据。纳入 2013 年至 2017 年期间接受 FAc 植入物的患者，并进行监测，直至最后一名患者达到≥3 年的随访期。分析了研究过程中的平均眼内压（IOP）数据、IOP 事件、IOP 降低治疗的使用、平均视力（VA）变化以及补充治疗使用信息。
695 只眼 556 例患者接受了 FAc 植入物治疗，平均随访时间为 1150.5±357.36 天。96.7%的眼患有慢性糖尿病黄斑水肿（cDMO）。34.5%的眼通过局部药物治疗和 4.3%的眼通过手术降低了 IOP。73 只眼（113 只非白内障眼的 64.6%）在随访期间需要进行白内障手术。平均 VA 从基线的 52.2 个字母增加到 36 个月时的 57.1 个字母，观察到 48 个月时仍有改善。43.7%的眼给予了补充治疗。根据 cDMO 的长短进行分类，病程较短的患者比病程较长的患者 VA 获益更大。
本研究证实了 FAc 植入物在 cDMO 眼中的长期有利风险状况，并在更早给予该治疗时为患者带来了额外的益处。
