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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.
Sponsor:
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00308477
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 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:

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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308477

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: 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:
Edema
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular 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

ClinicalTrials.gov processed this record on June 18, 2013