Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial
Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial
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DOI：
10.1080/09273948.2021.1954199
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发表时间：
2021-08-20
影响因子：
3.3
通讯作者：
Ciulla, Thomas A.
中科院分区：
文献类型：
--
作者：
Merrill, Pauline T.;Henry, Christopher R.;Ciulla, Thomas A.
目的观察脉络膜上腔注射曲安奈德混悬液治疗葡萄膜炎性黄斑水肿（UME）的疗效和安全性。方法对PEACHTREE 3期随机试验进行事后分析。结果在未接受ST治疗的UME患者中，在第24周，68名CLS-TA患者的平均BCVA变化为+15.6个字母，而49名假手术对照患者的平均BCVA变化为+4.9个字母（p < .001），而平均CST变化分别为-169.8 μ m和-10.3 μ m（p < .001）。在接受ST治疗的患者中，第24周时，28名CLS-TA患者的平均BCVA变化为+9.4个字母，而15名假手术对照患者为-3.2个字母（p = 0.019），而平均CST变化分别为-108.3 μ m和-43.5 μ m（p = 0.190）。未报告与治疗相关的严重不良事件。结论：在UME患者中，无论是否同时使用ST，CLS-TA均具有临床意义的获益。
Purpose To study the efficacy and safety of suprachoroidal CLS-TA (proprietary suspension of triamcinolone acetonide) in uveitic macular edema (UME) with and without concurrent systemic corticosteroid or steroid-sparing therapy (ST). Methods Post hoc analysis of the PEACHTREE phase 3 randomized trial. Results Among UME patients receiving no ST, at week 24, mean BCVA change was +15.6 letters in 68 CLS-TA patients versus +4.9 letters in 49 sham-control patients (p < .001), while mean CST change was -169.8 mu m versus -10.3 mu m, respectively (p < .001). Among patients receiving ST, at week 24, mean BCVA change was +9.4 letters in 28 CLS-TA patients versus -3.2 letters in 15 sham-control patients (p = .019), while mean CST change was -108.3 mu m versus -43.5 mu m, respectively (p = .190). No SAEs related to treatment were reported. Conclusions A clinically meaningful benefit of CLS-TA was noted in UME patients, regardless of concurrent ST usage.