Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema - Tabular View

Tracking Information

First Received Date ^ICMJE

April 20, 2007

Last Updated Date

July 10, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Visual Acuity

Change History

Complete list of historical versions of study NCT00464685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Macular Thickness (OCT) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Vessel leakage (FA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Time to retreatment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Macular Thickness, Quality of Life

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Official Title ^ICMJE

Brief Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Drug: Dexamethasone
Drug: Sham injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

254

Estimated Completion Date

May 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age or older with diabetic macular edema
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

Known anticipated need for ocular surgery within next 12 months
History of glaucoma or current high eye pressure requiring more than 1 medication
Uncontrolled systemic disease
Known steroid-responder
Use of systemic steroids - Use of Warfarin/Heparin

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00464685

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

206207-012

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP