NCT00308477

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

First QC Date

March 27, 2006

Last Update Submit

February 9, 2012

Conditions

Macular DegenerationMacular EdemaBranch Retinal Vein Occlusion

Keywords

eye diseases

Interventions

dexamethasoneDRUG

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kagawa, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Mie, Japan

Location

Unknown Facility

Miyazaki, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Shiga, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Macular DegenerationMacular EdemaRetinal Vein OcclusionEye Diseases

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Clinical Study Group, Clinical Development Dept.

    Sanwa Kagaku Kenkyusho Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

JP(12)