Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedJuly 21, 2014
July 1, 2014
August 4, 2011
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity(BCVA)
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary Outcomes (1)
retinal thickness
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provided signed, written informed consent
- years of age or older with diabetic macular edema
You may not qualify if:
- Active proliferative diabetic retinopathies (PDR) in the study eye
- Uncontrolled diabetes mellitus and hypertension
- Known steroid-responder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santen study sites
Osaka, Osaka, Japan
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 8, 2011
Last Updated
July 21, 2014
Record last verified: 2014-07