Phase II/III clinical trial of sub-tenon injection of triamcinolone acetonide (WP-0508ST) for diabetic macular Edema

Yuichiro Ogura, Masahiko Shimura, Tomohiro Iida, Taiji Sakamoto, Nagahisa Yoshimura, Mie Yamada, Tatsuro Ishibashi

研究成果: ジャーナルへの寄稿記事

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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.

元の言語英語
ページ(範囲)161-169
ページ数9
ジャーナルOphthalmologica
241
発行部数3
DOI
出版物ステータス出版済み - 3 1 2019

All Science Journal Classification (ASJC) codes

  • Ophthalmology
  • Sensory Systems

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