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Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
This study is ongoing, but not recruiting participants.
Study NCT00464685   Information provided by Allergan
First Received: April 20, 2007   Last Updated: July 10, 2009   History of Changes

April 20, 2007
July 10, 2009
May 2007
January 2010   (final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Visual Acuity
Complete list of historical versions of study NCT00464685 on ClinicalTrials.gov Archive Site
  • 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 ]
Macular Thickness, Quality of Life
 
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
 

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Diabetic Macular Edema
  • Drug: Dexamethasone
  • Drug: Sham injection
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
254
May 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00464685
Therapeutic Area Head, Allergan, Inc.
206207-012
Allergan
 
Study Director: Medical Director Allergan
Allergan
July 2009

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