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

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Betamethasone Microsphere (DE-102） Low Dose; Drug: Betamethasone Microsphere (DE-102） High Dose; Drug: Sham

• Registration Number: NCT01411254
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Betamethasone Microsphere (DE-102） Low Dose	-
2	Betamethasone Microsphere (DE-102） High Dose	-
3	Sham	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
retinal thickness		Change in retinal thickness from baseline

Trial Locations

Locations (1)

Santen study sites; 🇯🇵 Osaka, Japan