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Betamethasone Microsphere in Diabetic Macular Edema (TSUBASA)
NCT01411254Phase 3
Key facts
- Status
- Completed
- Countries
- 1
- Sponsor
- Santen Pharmaceutical
- Modality
- Orthosteric Ligands
- Drugs
- betamethasone
- Conditions
- diabetic macular edema (DME)
01
Overview
Phase 3, randomised, double-blind trial of betamethasone in diabetic macular edema (DME) (3 arms), sponsored by Santen Pharmaceutical. Primary endpoint: Best Corrected Visual Acuity. Status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Low Dose
Betamethasone Microsphere Low Dose
High Dose
Betamethasone Microsphere High Dose
Sham
Sham Comparator
03
Who it enrols
Patients 20 years or older with diabetic macular edema, excluding those with active proliferative diabetic retinopathy, uncontrolled diabetes or hypertension, or known steroid responders.
04
Endpoints
Primary
Best Corrected Visual Acuity
Secondary
Retinal Thickness
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