Safety and Efficacy of CLS-TA by Anatomic Location of Inflammation: Results from the Phase 3 PEACHTREE Clinical Trial.

IF 2.6 4区 医学 Q2 OPHTHALMOLOGY Ocular Immunology and Inflammation Pub Date : 2024-10-01 Epub Date: 2024-01-09 DOI:10.1080/09273948.2023.2262015
Milan Shah, Thomas Albini, Quan Nguyen, Charles Wykoff, Mark Barakat, Rahul N Khurana, Barry Kapik, Thomas A Ciulla
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引用次数: 0

Abstract

Purpose: To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype.

Methods: Patients diagnosed with ME associated with NIU of any etiology and anatomic subtype were eligible for the phase 3 PEACHTREE trial of CLS-TA. Post-hoc analyses were performed, stratified by discrete anatomic subtype of uveitis (anterior, intermediate, posterior, and panuveitis.).

Results: Across all anatomic subtypes at 24 weeks, patients receiving CLS-TA at baseline and week 12 demonstrated mean increases in BCVA ranging from +12.1 to +15.9 letters, mean central subfield thickness (CST) improvement ranging from -120.1 µm to -189.0 µm, and IOP changes ranging from +0.5 to +3.1 mmHg. Overall, reports of adverse events were similar among subtypes.

Conclusions: Irrespective of the uveitic anatomic subtype among patients treated for ME associated with NIU, a clinical benefit in participants treated with CLS-TA was demonstrated, with a comparable safety profile.

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按炎症解剖位置划分的 CLS-TA 的安全性和有效性:PEACHTREE 3 期临床试验结果。
目的:探讨CLS-TA(一种专有的脉络膜上注射用曲安奈德混悬液)对伴有黄斑水肿(ME)的非感染性葡萄膜炎(NIU)的疗效:被诊断为伴有任何病因和解剖亚型NIU的ME患者有资格参加CLS-TA的3期PEACHTREE试验。根据葡萄膜炎的不同解剖亚型(前葡萄膜炎、中间葡萄膜炎、后葡萄膜炎和泛葡萄膜炎)进行了事后分析:结果:24周时,在所有解剖亚型中,基线和第12周时接受CLS-TA治疗的患者BCVA平均增加了+12.1到+15.9个字母,中央子场厚度(CST)平均改善了-120.1到-189.0微米,眼压变化了+0.5到+3.1毫米汞柱。总体而言,各亚型的不良反应报告相似:结论:在接受与NIU相关的ME治疗的患者中,无论葡萄膜解剖亚型如何,接受CLS-TA治疗的患者都能获得临床获益,且安全性相当。
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来源期刊
CiteScore
6.20
自引率
15.20%
发文量
285
审稿时长
6-12 weeks
期刊介绍: Ocular Immunology & Inflammation ranks 18 out of 59 in the Ophthalmology Category.Ocular Immunology and Inflammation is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and vision scientists. Published bimonthly, the journal provides an international medium for basic and clinical research reports on the ocular inflammatory response and its control by the immune system. The journal publishes original research papers, case reports, reviews, letters to the editor, meeting abstracts, and invited editorials.
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