NCT02302079

A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)

A Phase 2, Double-Masked, Randomized, Active Controlled Study to Evaluate the Efficacy and Safety of ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.

Conditions

• Diabetes Mellitus
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	ASP8232	oral capsule
DRUG	ranibizumab	intravitreal (IVT) injection
DRUG	Placebo	oral capsule
OTHER	Sham intravitreal (IVT) injection	intravitreal (IVT) injection

Timeline

• Start date: 2015-01-12
• Primary completion: 2016-08-12
• Completion: 2016-08-12
• First posted: 2014-11-26
• Last updated: 2024-10-31

Locations

21 sites across 1 country: United States