治疗糖尿病黄斑水肿的 0.2µg/天氟轻松醋酸酯眼内植入物的两年中期安全性结果：观察性 PALADIN 研究。
Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study.
机构信息
Ophthalmology, George Washington University, Washington, District of Columbia, USA
Virginia Retina Center, Warrenton, Virginia, USA.
出版信息
Br J Ophthalmol. 2021 Mar;105(3):414-419. doi: 10.1136/bjophthalmol-2020-315984. Epub 2020 May 27.
BACKGROUND
The 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO.
METHODS
This 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured.
RESULTS
Data were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1-3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041).
CONCLUSION
Few IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge.
TRIAL REGISTRATION NUMBER
NCT02424019.
背景
每天 0.2 微克氟轻松丙酮（FAc）植入物为治疗糖尿病性黄斑水肿（DMO）提供持续的、低剂量的眼内皮质类固醇。这项正在进行的、为期 3 年的观察性临床试验为 DMO 中的 FAc 植入物提供了长期的、“真实世界”的安全性结果。
方法
这是一项前瞻性观察性研究的 24 个月中期分析，研究对象为接受市售 0.2 微克/天 FAc 眼内植入物治疗的 DMO 患者。主要结局是眼压（IOP）降低手术的发生率。还测量了其他与 IOP 相关的信号及其与先前皮质类固醇暴露、最佳矫正视力、中央视网膜厚度（CST）、眼部不良事件和其他治疗的频率之间的关系。
结果
在 FAc 植入前最多 36 个月和 FAc 植入后 24 个月，共收集了 95 名先前接受过皮质类固醇挑战的患者（115 只研究眼）的数据。总体人群的 IOP 在 FAc 植入后保持稳定，与 FAc 植入前相比。与 IOP 相关的手术仍然很少见（FAc 植入前两次 IOP 降低手术；两次小梁成形术和四次 IOP 降低手术）。FAc 植入后视力稳定（平均提高 1-3 个字母），并且每年所需的 DMO 治疗次数减少。FAc 植入后 24 个月 CST 显著降低（p<0.001），并且 CST≤300 µm 的患者比例显著增加（p=0.041）。
结论
在 FAc 植入后 24 个月内报告的与 IOP 相关的手术很少。治疗后观察到了积极的疗效结果，视力稳定，炎症减轻，表现为 CST。FAc 植入物在 DMO 的管理中具有良好的获益风险比，特别是在先前接受类固醇挑战后使用时。
试验注册号
NCT02424019。
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