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

August 4, 2011
June 7, 2012
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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.
 
Recruiting
Not Provided
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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
Both
20 Years and older
No
Contact: Santen Pharmaceutical Co., Ltd. +81-6-6321-7109 clinical@santen.co.jp
Japan
 
NCT01411254
01021103
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
June 2012

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