ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00308477
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : February 13, 2012
Sponsor:
Information provided by:
Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Macular Degeneration Macular Edema Branch Retinal Vein Occlusion 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

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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.

ClinicalTrials.gov Identifier: NCT00308477     History of Changes
Other Study ID Numbers: DX4001
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

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
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents