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

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.
ClinicalTrials.gov Identifier: NCT01411254
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : July 21, 2014
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.

Brief Summary:
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Condition or disease Intervention/treatment 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  (Clinical Trial)
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 the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Betamethasone Microsphere (DE-102) Low Dose
Experimental: 2 Drug: Betamethasone Microsphere (DE-102) High Dose
Sham Comparator: 3 Drug: Sham



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


Secondary Outcome Measures :
  1. retinal thickness
    Change in retinal thickness from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411254


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

ClinicalTrials.gov Identifier: NCT01411254     History of Changes
Other Study ID Numbers: 01021103
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

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 benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents