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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

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 the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.

Condition Intervention Phase
Macular Degeneration
Macular Edema
Branch Retinal Vein Occlusion
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:

  • Macular edema resulting from branch retinal vein condition
  • The criteria for visual acuity and macular thickness are met

Exclusion Criteria:

  • History of glaucoma
  • Diabetic retinopathy
  • Known steroid-responder
  • Use of systemic steroids
  • Use of Warfarin/Heparin
  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: NCT00308477

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: NCT00308477     History of Changes
Other Study ID Numbers: DX4001 
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

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular 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 21, 2016