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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 27, 2006

Last Updated Date

October 8, 2008

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00308542 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Brief Summary

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

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Macular Edema

Intervention ^†

Drug: dexamethasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Clinical Development Department, Sanwa Kagaku Kenkyusho Co., Ltd.

81-52-951-8130

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00308542

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Sanwa Kagaku Kenkyusho Co., Ltd.

Collaborators ^††

Investigators ^†

Study Director:

Clinical Study Group, Clinical Development Dept.

Sanwa Kagaku Kenkyusho Co., Ltd.

Information Provided By

Sanwa Kagaku Kenkyusho Co., Ltd.

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.