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

Santen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Sham; Drug: Betamethasone Microsphere (DE-102） Low Dose; Drug: Betamethasone Microsphere (DE-102） High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01411254

01021103

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Betamethasone Microsphere (DE-102） Low Dose

2

Experimental group

Treatment:

Drug: Betamethasone Microsphere (DE-102） High Dose

3

Sham Comparator group

Treatment:

Drug: Sham