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

This study has been completed.
Sponsor:
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00308542
First received: March 27, 2006
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  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 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:

MedlinePlus related topics: Edema Eye Diseases
U.S. FDA Resources

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

  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

Locations
Japan
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.
Investigators
Study Director: Clinical Study Group, Clinical Development Dept. Sanwa Kagaku Kenkyusho Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov 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:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013