Phase II/III Clinical Trial of Sub-Tenon Injection of Triamcinolone Acetonide (WP-0508ST) for Diabetic Macular Edema
Phase II/III Clinical Trial of Sub-Tenon Injection of Triamcinolone Acetonide (WP-0508ST) for Diabetic Macular Edema
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DOI：
10.1159/000492135
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发表时间：
2019-01-01
期刊：
影响因子：
2.6
通讯作者：
Ishibashi, Tatsuro
中科院分区：
文献类型：
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作者：
Ogura, Yuichiro;Shimura, Masahiko;Ishibashi, Tatsuro
目的：目的评价Tenon下注射曲安奈德（WP-0508 ST）治疗糖尿病性黄斑水肿（DME）的疗效和安全性。方法：这项多中心、随机、双盲、比较、对照研究在95例DME患者中进行。将患者随机分为20 mg WP-0508 ST组、40 mg WP-0508 ST组和对照组。结果如下：在单次Tenon下注射20 mg WP-0508 ST后12周，观察到中心黄斑厚度（CMT）的显著改善（p < 0.001）。40 mg组的CMT也有所改善，但差异不显著。此外，在12周时，20 mg和40 mg组的最佳矫正视力均得到改善。主要副作用为眼内压升高（20 mg组为9.4%，40 mg组为13.3%）和晶状体混浊（20 mg组为6.3%，40 mg组为10.0%）。然而，没有眼内压升高的患者需要手术。结论：WP-0508 ST治疗DME的有效性和耐受性得到证实，确定20 mg为最佳剂量。(c)2018 S. Karger AG，巴塞尔
Purpose: To assess the efficacy and safety of sub-Tenon injection of triamcinolone acetonide (WP-0508ST) for the patients with diabetic macular edema (DME). Methods: This multicenter, randomized, double-masked, comparative, controlled study was performed in 95 patients with DME. The patients were randomly divided into 20 mg WP-0508ST, 40 mg WP-0508ST, and control groups. Results: A significant improvement in central macular thickness (CMT) was observed (p < 0.001) at 12 weeks after a single sub-Tenon injection of 20 mg WP-0508ST. The 40 mg group also demonstrated improvement in CMT, but the difference was not significant. In addition, the best-corrected visual acuity was improved in both the 20 mg and 40 mg groups at 12 weeks. The major side effects were increased intraocular pressure (9.4% in the 20 mg group and 13.3% in the 40 mg group) and lenticular opacity (6.3% in the 20 mg group and 10.0% in the 40 mg group). However, none of the patients with increased intraocular pressure required surgery. Conclusion: The efficacy and tolerability of WP-0508ST in the treatment of DME were confirmed, and 20 mg was determined to be the optimal dose. (c) 2018 S. Karger AG, Basel