Aim To evaluate the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX; Ozurdex) monotherapy in the patient subgroup of the AUSSIEDEX study with treatment-naïve diabetic macular oedema (DME). Methods The open-label, prospective, phase 4, real-world study included pseudophakic eyes and phakic eyes scheduled for cataract surgery that were treatment-naïve or non-responsive to antivascular endothelial growth factors. No eyes were excluded based on baseline best-corrected visual acuity (BCVA) or central subfield retinal thickness (CRT). After the initial DEX injection at the baseline visit, reinjection was permitted at ≥16-week intervals. Week-16 and week-52 visits were mandatory. Primary endpoints were changes in mean BCVA and CRT from baseline to 52 weeks. Results Of 200 eyes enrolled in the AUSSIEDEX study, 57 were treatment-naïve. Baseline mean BCVA was 58.8 letters and baseline mean CRT was 418.6 µm; changes in mean BCVA and CRT from baseline to 52 weeks in this subgroup were 3.4 letters (p=0.042) and –89.6 µm (p<0.001), respectively, with a mean 2.5 injections. The change in mean CRT from baseline was –55.8 µm at week 16 (p<0.001). The most common adverse event was increased intraocular pressure (IOP), with 20.0% of eyes requiring IOP-lowering medication. One patient was discontinued due to increased IOP. No eyes required filtration surgery. No serious, treatment-related ocular adverse events were reported. Conclusion In this largest prospective, real-world study of DEX monotherapy for DME to date, DEX significantly improved CRT and BCVA at 52 weeks in treatment-naïve eyes, without new safety concerns, supporting DEX use in treatment-naïve DME. Trial registration number [NCT02731911][1]. Data are available on reasonable request. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymised, individual and trial-level data (analysis data sets), as well as other information (eg, protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: . [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02731911&atom=%2Fbjophthalmol%2F107%2F1%2F72.atom

中文翻译：

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地塞米松玻璃体内植入物治疗初治糖尿病性黄斑水肿：来自前瞻性、多中心、AUSSIEDEX 研究的结果

目的 评估地塞米松玻璃体内植入物 0.7 mg（DEX；Ozurdex）单一疗法在 AUSSIEDEX 研究的初治糖尿病黄斑水肿 (DME) 患者亚组中的有效性。方法 开放标签、前瞻性、第 4 期、真实世界研究包括拟行白内障手术的假晶状体眼和有晶状体眼，这些眼未接受过治疗或对抗血管内皮生长因子无反应。根据基线最佳矫正视力 (BCVA) 或中央子视野视网膜厚度 (CRT)，没有眼睛被排除在外。在基线访问时初始 DEX 注射后，允许以≥16 周的间隔重新注射。第 16 周和第 52 周的访问是强制性的。主要终点是平均 BCVA 和 CRT 从基线到 52 周的变化。结果 在参加 AUSSIEDEX 研究的 200 只眼中，57 只未接受过治疗。基线平均 BCVA 为 58.8 个字母，基线平均 CRT 为 418.6 µm；该亚组从基线到 52 周的平均 BCVA 和 CRT 变化分别为 3.4 个字母 (p=0.042) 和 –89.6 µm (p<0.001)，平均注射 2.5 次。第 16 周时平均 CRT 相对于基线的变化为 –55.8 µm (p<0.001)。最常见的不良事件是眼内压 (IOP) 升高，20.0% 的眼睛需要降低眼压的药物。一名患者因 IOP 升高而停药。没有眼睛需要过滤手术。没有报告严重的、治疗相关的眼部不良事件。结论 在这项迄今为止最大的 DEX 单药治疗 DME 前瞻性真实世界研究中，DEX 在 52 周时显着改善了初治眼的 CRT 和 BCVA，没有新的安全问题，支持 DEX 在初治 DME 中的使用。试用注册号[NCT02731911][1]。可应合理要求提供数据。AbbVie 致力于负责任地共享有关我们赞助的临床试验的数据。这包括访问匿名、个人和试验级数据（分析数据集）以及其他信息（例如协议和临床研究报告），只要试验不是正在进行或计划中的监管提交的一部分。这包括对未经许可的产品和适应症的临床试验数据的请求。任何从事严谨、独立科学研究的合格研究人员均可索取此临床试验数据，并将在研究计划和统计分析计划 (SAP) 审​​查和批准以及数据共享协议 (DSA) 执行后提供。可以随时提交数据请求，数据的访问期限为 12 个月，并考虑可能的延期。有关流程的更多信息或提交请求，请访问以下链接：. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02731911&atom=%2Fbjophthalmol%2F107%2F1%2F72.atom