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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Betamethasone Microsphere (DE-102） Low Dose
Betamethasone Microsphere (DE-102） High Dose
Sham
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Diabetic Macular Edema focused on measuring DME

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santen study sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

1

2

3

Arm Description

Outcomes

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

Full Information

First Posted
August 4, 2011
Last Updated
July 17, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01411254
Brief Title
Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
DME

7. Study Design

Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethasone Microsphere (DE-102） Low Dose
Intervention Type
Drug
Intervention Name(s)
Betamethasone Microsphere (DE-102） High Dose
Intervention Type
Drug
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity(BCVA)
Description
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary Outcome Measure Information:
Title
retinal thickness
Description
Change in retinal thickness from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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