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

NCT02302079 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-10-31

No results posted yet for this study

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

Interventions

DRUG

ASP8232

oral capsule

DRUG

ranibizumab

intravitreal (IVT) injection

DRUG

Placebo

oral capsule

OTHER

Sham intravitreal (IVT) injection

intravitreal (IVT) injection

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Global Medical Lead · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302079 on ClinicalTrials.gov