NCT00308542

Brief Summary

This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

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

Diabetic Macular Edema

Keywords

eye diseasesdiabetic eye problems

Interventions

dexamethasoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Diabetic macular edema
  • Criteria for visual acuity and macular thickness are met

You may not qualify if:

  • History of glaucoma
  • 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

Eye Diseases

Interventions

Dexamethasone

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)