Back to resultsA Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring eye diseases, diabetic eye problems
Eligibility Criteria
Inclusion Criteria: Diabetic macular edema Criteria for visual acuity and macular thickness are met Exclusion Criteria: History of glaucoma Known steroid-responder Use of systemic steroids Use of Warfarin/Heparin Other protocol-defined exclusion criteria may apply
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00308542
First Posted
March 27, 2006
Last Updated
February 9, 2012
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00308542
Brief Title
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
eye diseases, diabetic eye problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexamethasone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic macular edema
Criteria for visual acuity and macular thickness are met
Exclusion Criteria:
History of glaucoma
Known steroid-responder
Use of systemic steroids
Use of Warfarin/Heparin
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Group, Clinical Development Dept.
Organizational Affiliation
Sanwa Kagaku Kenkyusho Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Gunma
Country
Japan
City
Hokkaido
Country
Japan
City
Kagawa
Country
Japan
City
Kyoto
Country
Japan
City
Mie
Country
Japan
City
Miyazaki
Country
Japan
City
Osaka
Country
Japan
City
Shiga
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
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