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

This study is currently recruiting participants.

Verified by Sanwa Kagaku Kenkyusho Co., Ltd., October 2008

Sponsored by:	Sanwa Kagaku Kenkyusho Co., Ltd.
Information provided by:	Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00308542

Purpose

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

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: dexamethasone	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308542

Contacts

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

81-52-951-8130

Locations

Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Gunma, Japan
	Recruiting
Chiba, Japan
	Recruiting
Tokyo, Japan
	Recruiting
Aichi, Japan
	Recruiting
Shiga, Japan
	Not yet recruiting
Miyazaki, Japan
	Recruiting
Osaka, Japan
	Recruiting
Kagawa, Japan
	Recruiting
Fukuoka, Japan
	Not yet recruiting
Mie, Japan
	Recruiting
Kyoto, Japan

Sponsors and Collaborators

Sanwa Kagaku Kenkyusho Co., Ltd.

Investigators

Study Director:

Clinical Study Group, Clinical Development Dept.

Sanwa Kagaku Kenkyusho Co., Ltd.

More Information

Study ID Numbers:	DX4002
Study First Received:	March 27, 2006
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00308542
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanwa Kagaku Kenkyusho Co., Ltd.:

eye diseases
diabetic eye problems

Study placed in the following topic categories:

Dexamethasone
Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Dexamethasone acetate
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009