drugset / Trial / NCT02302079

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

NCT02302079

Phase 2 Completed 96 enrolled Astellas Pharma Europe B.V.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2015-01-12
Primary completion
2016-08-12
Completion
2016-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP8232 Small molecule 40 mg Oral
Subject Ranibizumab Monoclonal antibody 0.3 mg Intravitreal