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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01411254
Enrollment
Unknown
Registered
2011-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2014-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

DME

Brief summary

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

Interventions

DRUGBetamethasone Microsphere (DE-102） Low Dose
DRUGBetamethasone Microsphere (DE-102） High Dose
DRUGSham

Sponsors

Santen Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity(BCVA)—Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score

Secondary

MeasureTime frameDescription
retinal thickness—Change in retinal thickness from baseline

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026