Aims To compare effectiveness of subconjunctival triamcinolone acetonide injections and intravitreal injections of dexamethasone 700 µg implants in reducing central macular thickness (CMT) in uveitic and postoperative macular oedema (ME). Methods We conducted an open-label, French multicentre randomised comparative trial with a logarithmic CMT non-inferiority margin set at 0.06. Patients were adults with non-infectious inflammatory ME, without any contraindication to the treatments. They were randomised 1:1 to receive either triamcinolone or dexamethasone. The primary endpoint was the difference in CMT among treated eyes between baseline and 2 months, measured with spectral-domain optical coherence tomography. Secondary outcomes included visual acuity, laser flare, vitreous haze, duration of action, tolerance to injections and adverse events. Results Between January 2016 and January 2020, 106 patients were enrolled (54 in the triamcinolone group and 52 in the dexamethasone group). Subconjunctival triamcinolone injections seemed to be non-inferior to intravitreal dexamethasone injections, especially at month 3 (and nearly at month 1). Nevertheless, we could not demonstrate it, with a treatment effect at month 2 of 0.05 (0.01 ; 0.09) (p value=0.001). This was corroborated by post hoc analyses in the postoperative subgroup, for whom the non-inferiority was nearly demonstrated at month 2 with a treatment effect of 0.02 (−0.03 ; 0.08) (p=0.37). There was no significant difference in the occurrence of adverse effects. Conclusion We could not demonstrate the non-inferiority of triamcinolone injections at month 2. Nevertheless, they showed some efficacity, particularly in treating postoperative ME, being as safe as dexamethasone injections, without any loss of chance if a therapeutic switch is necessary. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information.

中文翻译：

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结膜下注射三安奈德与玻璃体内注射地塞米松 (OZurdex) 治疗葡萄膜炎和术后黄斑水肿的比较：TRIOZ 研究


目的 比较结膜下注射曲安奈德和玻璃体内注射地塞米松 700 µg 植入物在减少葡萄膜炎和术后黄斑水肿 (ME) 黄斑中心厚度 (CMT) 方面的效果。方法 我们进行了一项开放标签、法国多中心随机比较试验，对数 CMT 非劣效性界限设置为 0.06。患者是患有非传染性炎症性 ME 的成年人，没有任何治疗禁忌。他们按照 1:1 的比例随机分配接受曲安西龙或地塞米松治疗。主要终点是治疗眼在基线和 2 个月之间 CMT 的差异，通过谱域光学相干断层扫描测量。次要结果包括视力、激光耀斑、玻璃体混浊、作用持续时间、注射耐受性和不良事件。结果 2016年1月至2020年1月期间，共纳入106例患者（曲安西龙组54例，地塞米松组52例）。结膜下注射曲安西龙似乎并不劣于玻璃体内注射地塞米松，尤其是在第 3 个月（以及接近第 1 个月）。然而，我们无法证明这一点，第 2 个月的治疗效果为 0.05 (0.01; 0.09) (p 值 = 0.001)。术后亚组的事后分析证实了这一点，在第 2 个月几乎就证明了非劣效性，治疗效果为 0.02（-0.03；0.08）（p=0.37）。不良反应的发生率没有显着差异。结论 我们无法证明曲安西龙注射液在第 2 个月时的非劣效性。 尽管如此，它们还是显示出了一定的功效，特别是在治疗术后 ME 方面，与注射地塞米松一样安全，如果需要进行治疗转换，也不会损失任何机会。可根据合理要求提供数据。与研究相关的所有数据都包含在文章中或作为在线补充信息上传。