CLS-TA 治疗非感染性葡萄膜炎相关黄斑水肿的安全性和有效性的扩展研究（MAGNOLIA）。
Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA).
机构信息
Northern California Retina-Vitreous Associates, Mountain View, California, USA
Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
出版信息
Br J Ophthalmol. 2022 Aug;106(8):1139-1144. doi: 10.1136/bjophthalmol-2020-317560. Epub 2021 Mar 12.
PURPOSE
To assess the extended efficacy and safety of suprachoroidal triamcinolone acetonide injectable suspension (CLS-TA) among patients with macular oedema (ME) secondary to non-infectious uveitis (NIU).
METHODS
Patients with uveitic ME were treated with suprachoroidal CLS-TA at baseline and week 12 of the Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial (PEACHTREE) study. Time to rescue was evaluated over 24 additional weeks for MAGNOLIA. Safety data, visual acuity and retinal central subfield thickness (CST) reduction were also evaluated. Of the 53 eligible patients (46 CLS-TA and 7 control), 33 patients were enrolled (28 CLS-TA and 5 control).
RESULTS
Over the entire 48-week period for PEACHTREE and MAGNOLIA, the median time to rescue therapy was 257 days versus 55.5 days for the CLS-TA and sham-control arms, respectively. Of 28 CLS-TA treated patients who participated in MAGNOLIA, 14 (50%) did not require rescue therapy through approximately 9 months after the second treatment. Among CLS-TA patients not requiring rescue, there was a mean gain of 12.1 letters and mean CST reduction of 174.5 µm at week 48. No serious adverse events related to study treatment were observed.
CONCLUSION
Approximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.
目的
评估玻璃体内曲安奈德注射悬浮液（CLS-TA）治疗非感染性葡萄膜炎（NIU）相关黄斑水肿（ME）的扩展疗效和安全性。
方法
葡萄膜炎性 ME 患者在 Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis：Phase 3 Randomized Trial（PEACHTREE）研究的基线和第 12 周时接受玻璃体内 CLS-TA 治疗。MAGNOLIA 研究评估了 24 周以上的挽救治疗时间。还评估了安全性数据、视力和视网膜中央小凹厚度（CST）的减少。在 53 名符合条件的患者（46 名 CLS-TA 和 7 名对照组）中，有 33 名患者入组（28 名 CLS-TA 和 5 名对照组）。
结果
在整个 48 周的 PEACHTREE 和 MAGNOLIA 研究期间，CLS-TA 组和假手术对照组的中位挽救治疗时间分别为 257 天和 55.5 天。在参加 MAGNOLIA 的 28 名接受 CLS-TA 治疗的患者中，有 14 名（50%）在第二次治疗后约 9 个月不需要挽救治疗。在不需要挽救治疗的 CLS-TA 患者中，第 48 周时平均视力提高了 12.1 个字母，CST 平均减少了 174.5μm。未观察到与研究治疗相关的严重不良事件。
结论
大约 50%的患者在最后一次 CLS-TA 给药后长达 9 个月内无需额外治疗。
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