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

This study has been completed.
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd. Identifier:
First received: March 27, 2006
Last updated: February 9, 2012
Last verified: February 2012
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 1
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Sanwa Kagaku Kenkyusho Co., Ltd.:


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.
  More Information Identifier: NCT00308542     History of Changes
Other Study ID Numbers: DX4002 
Study First Received: March 27, 2006
Last Updated: February 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 processed this record on October 27, 2016