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

This study has been completed.
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
First received: August 4, 2011
Last updated: July 17, 2014
Last verified: July 2014
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Condition Intervention Phase
Diabetic Macular Edema
Drug: Betamethasone Microsphere (DE-102) Low Dose
Drug: Betamethasone Microsphere (DE-102) High Dose
Drug: Sham
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Best Corrected Visual Acuity(BCVA)
    Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score

Secondary Outcome Measures:
  • retinal thickness
    Change in retinal thickness from baseline

Arms Assigned Interventions
Experimental: 1 Drug: Betamethasone Microsphere (DE-102) Low Dose
Experimental: 2 Drug: Betamethasone Microsphere (DE-102) High Dose
Sham Comparator: 3 Drug: Sham


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411254

Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT01411254     History of Changes
Other Study ID Numbers: 01021103 
Study First Received: August 4, 2011
Last Updated: July 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Santen Pharmaceutical Co., Ltd.:

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016