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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308542
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : February 13, 2012
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: dexamethasone Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308542

Aichi, Japan
Chiba, Japan
Fukuoka, Japan
Gunma, Japan
Hokkaido, Japan
Kagawa, Japan
Kyoto, Japan
Mie, Japan
Miyazaki, Japan
Osaka, Japan
Shiga, Japan
Tokyo, Japan
Sponsors and Collaborators
Sanwa Kagaku Kenkyusho Co., Ltd.
Study Director: Clinical Study Group, Clinical Development Dept. Sanwa Kagaku Kenkyusho Co., Ltd. Identifier: NCT00308542     History of Changes
Other Study ID Numbers: DX4002
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Sanwa Kagaku Kenkyusho Co., Ltd.:
eye diseases
diabetic eye problems

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents