Phase II/III Clinical Trial of Sub-Tenon Injection of Triamcinolone Acetonide (WP-0508ST) for Diabetic Macular Edema.
Adult
Aged
Diabetic Retinopathy
/ complications
Dose-Response Relationship, Drug
Double-Blind Method
Female
Fluorescein Angiography
/ methods
Follow-Up Studies
Fundus Oculi
Glucocorticoids
/ administration & dosage
Humans
Injections, Intraocular
Macular Edema
/ diagnosis
Male
Middle Aged
Tenon Capsule
Time Factors
Tomography, Optical Coherence
/ methods
Treatment Outcome
Triamcinolone Acetonide
/ administration & dosage
Visual Acuity
Diabetic macular edema
Randomized clinical study
Sub-Tenon injection
Triamcinolone acetonide
WP-0508ST
Journal
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde
ISSN: 1423-0267
Titre abrégé: Ophthalmologica
Pays: Switzerland
ID NLM: 0054655
Informations de publication
Date de publication:
2019
2019
Historique:
received:
10
05
2018
accepted:
13
07
2018
pubmed:
4
9
2018
medline:
11
4
2019
entrez:
4
9
2018
Statut:
ppublish
Résumé
To assess the efficacy and safety of sub-Tenon injection of triamcinolone acetonide (WP-0508ST) for the patients with diabetic macular edema (DME). 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. 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. The efficacy and tolerability of WP-0508ST in the treatment of DME were confirmed, and 20 mg was determined to be the optimal dose.
Identifiants
pubmed: 30176671
pii: 000492135
doi: 10.1159/000492135
doi:
Substances chimiques
Glucocorticoids
0
Triamcinolone Acetonide
F446C597KA
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
161-169Informations de copyright
© 2018 S. Karger AG, Basel.