Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)

Phase 3CompletedNCT01411254

Santen Pharmaceutical Co., Ltd.

Overview

This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Study Type

INTERVENTIONAL

Conditions

Diabetic Macular Edema

Interventions

Betamethasone Microsphere (DE-102） Low DoseDRUG

Betamethasone Microsphere (DE-102） High DoseDRUG

ShamDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provided signed, written informed consent * 20 years of age or older with diabetic macular edema Exclusion Criteria: * Active proliferative diabetic retinopathies (PDR) in the study eye * Uncontrolled diabetes mellitus and hypertension * Known steroid-responder

Locations (1)

Santen study sites

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Best Corrected Visual Acuity(BCVA)

Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score

Secondary Outcomes

retinal thickness

Change in retinal thickness from baseline

Data from ClinicalTrials.gov

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