We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411254
First Posted: August 8, 2011
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santen Pharmaceutical Co., Ltd.
August 4, 2011
August 8, 2011
July 21, 2014
Not Provided
Not Provided
Best Corrected Visual Acuity(BCVA)
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Same as current
Complete list of historical versions of study NCT01411254 on ClinicalTrials.gov Archive Site
retinal thickness
Change in retinal thickness from baseline
Same as current
Not Provided
Not Provided
 
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
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
Not Provided
Interventional
Phase 2
Phase 3
Not Provided
Diabetic Macular Edema
  • Drug: Betamethasone Microsphere (DE-102) Low Dose
  • Drug: Betamethasone Microsphere (DE-102) High Dose
  • Drug: Sham
  • Experimental: 1
    Intervention: Drug: Betamethasone Microsphere (DE-102) Low Dose
  • Experimental: 2
    Intervention: Drug: Betamethasone Microsphere (DE-102) High Dose
  • Sham Comparator: 3
    Intervention: Drug: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01411254
01021103
Not Provided
Not Provided
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
To Top