Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA).
Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA).
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DOI：
10.1136/bjophthalmol-2020-317560
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发表时间：
2022-08
影响因子：
4.1
通讯作者：
Ciulla, Thomas
中科院分区：
文献类型：
--
作者：
Khurana, Rahul N.;Merrill, Pauline;Yeh, Steven;Suhler, Eric;Barakat, Mark R.;Uchiyama, Eduardo;Henry, Christopher Ryan;Shah, Milan;Wang, Robert C.;Kapik, Barry;Ciulla, Thomas
目的：评价脉络膜上腔曲安奈德可注射混悬液(CLS-TA)治疗非感染性葡萄膜炎(NIU)继发黄斑水肿(ME)的远期疗效和安全性。在脉络膜上CLS-TA对继发于非感染性葡萄膜炎的黄斑水肿的有效性和安全性：第3阶段随机试验(桃树)研究的基线和第12周，葡萄膜炎ME患者接受脉络膜上CLS-TA治疗。对木兰花的救援时间进行了超过24周的评估。对安全性数据、视力和视网膜中央亚野厚度(CST)减少率进行评估。在53例符合条件的患者中(46例CLS-TA和7例对照)，33例患者入选(28例CLS-TA和5例对照)。在整个48周期间，桃树和木兰花的中位抢救治疗时间为257天，而CLS-TA组和假对照组分别为55.5 天。在参与白玉兰治疗的28名接受CLS-TA治疗的患者中，14名(50%)在第二次治疗后大约9个月内没有需要救援治疗。在不需要抢救的CLS-TA患者中，48周时平均增加了12.1个字母，平均降低了174.5 微米。未观察到与研究治疗相关的严重不良事件。大约50%的患者在最后一次使用CLS-TA后的9个月内不需要额外的治疗。
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). 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). 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. Approximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.
脉络膜上注射曲安奈德作为受控眼部药物释放模型的安全性和药效学
影响因子：
10.8
作者：
Chen, Mei;Li, Xiaoli;Cheng, Lingyun
通讯作者：
Cheng, Lingyun
影响因子：
13.7
作者：
Thorne JE;Sugar EA;Holbrook JT;Burke AE;Altaweel MM;Vitale AT;Acharya NR;Kempen JH;Jabs DA;Multicenter Uveitis Steroid Treatment Trial Research Group
通讯作者：
Multicenter Uveitis Steroid Treatment Trial Research Group
影响因子：
13.7
作者：
Yeh, Steven;Khurana, Rahul N.;Noronha, Glenn
通讯作者：
Noronha, Glenn