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

This study is currently recruiting participants.
Verified June 2012 by Santen Pharmaceutical Co., Ltd.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01411254
First received: August 4, 2011
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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

Contacts
Contact: Santen Pharmaceutical Co., Ltd. +81-6-6321-7109 clinical@santen.co.jp

Locations
Japan
Santen study sites Recruiting
Osaka, Japan
Contact: Santen Pharmaceutical Co., Ltd.     +81-6-6321-7109     clinical@santen.co.jp    
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: June 7, 2012
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 May 23, 2013