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NCT00308542 Clinical Trial

A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308542
Other study ID # DX4002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 27, 2006
Last updated February 9, 2012

Study information
Verified date February 2012
Source Sanwa Kagaku Kenkyusho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• dexamethasone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

See also
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