NCT00168337

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Dexamethasone	350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
OTHER	Sham	Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Timeline

• Start date: 2005-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2005-09-15
• Last updated: 2014-08-04
• Results posted: 2014-08-04

Locations

14 sites across 14 countries: United States, Brazil, Canada, Colombia, France, Hungary, India, Italy, New Zealand, Poland, Singapore, South Korea, Taiwan, United Kingdom