Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
Information source: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Edema
Intervention: Betamethasone Microsphere (DE-102) Low Dose (Drug); Betamethasone Microsphere (DE-102) High Dose (Drug); Sham (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Santen Pharmaceutical Co., Ltd.
Summary
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for
diabetic macular edema.
Clinical Details
Official title: A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
Study design: N/A
Primary outcome: Best Corrected Visual Acuity(BCVA)
Secondary outcome: retinal thickness
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Santen study sites, Osaka, Japan
Additional Information
Last updated: July 17, 2014
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