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

Journal: Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde 2019;241(3):161-169

PMID: 30176671

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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.

Address: Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.; Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.; Department of Ophthalmology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.; Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.; Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.; Clinical Development Department, Wakamoto Pharmaceutical Company, Ltd., Tokyo, Japan, [email protected].; Department of Ophthalmology, Kyusyu University Hospital, Fukuoka, Japan.

DOI: 10.1159/000492135

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https://doi.org/10.1159/000492135

MeSH Terms: Adult, Aged, Diabetic Retinopathy, Dose-Response Relationship, Drug, Double-Blind Method, Female, Fluorescein Angiography, Follow-Up Studies, Fundus Oculi, Glucocorticoids, Humans, Injections, Intraocular, Macular Edema, Male, Middle Aged, Tenon Capsule, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Triamcinolone Acetonide, Visual Acuity