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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)161-169
Number of pages9
JournalOphthalmologica
Volume241
Issue number3
DOIs
Publication statusPublished - Mar 1 2019

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Triamcinolone Acetonide
Phase III Clinical Trials
Phase II Clinical Trials
Macular Edema
Injections
Intraocular Pressure
Visual Acuity
Safety
Control Groups
Therapeutics

All Science Journal Classification (ASJC) codes

  • Ophthalmology
  • Sensory Systems

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Phase II/III clinical trial of sub-tenon injection of triamcinolone acetonide (WP-0508ST) for diabetic macular Edema. / Ogura, Yuichiro; Shimura, Masahiko; Iida, Tomohiro; Sakamoto, Taiji; Yoshimura, Nagahisa; Yamada, Mie; Ishibashi, Tatsuro.

In: Ophthalmologica, Vol. 241, No. 3, 01.03.2019, p. 161-169.

Research output: Contribution to journalArticle

Ogura, Yuichiro ; Shimura, Masahiko ; Iida, Tomohiro ; Sakamoto, Taiji ; Yoshimura, Nagahisa ; Yamada, Mie ; Ishibashi, Tatsuro. / Phase II/III clinical trial of sub-tenon injection of triamcinolone acetonide (WP-0508ST) for diabetic macular Edema. In: Ophthalmologica. 2019 ; Vol. 241, No. 3. pp. 161-169.
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abstract = "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.",
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