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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01411254
First received: August 4, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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

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

No publications provided

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.:
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014