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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Pharmaceutical Co., Ltd.
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

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