NCT00464685

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Dexamethasone	Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
DRUG	Sham injection	Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
PROCEDURE	Laser Photocoagulation	Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-02-08
• Completion: 2010-02-08
• First posted: 2007-04-24
• Last updated: 2019-04-24
• Results posted: 2014-08-04

Locations

2 sites across 2 countries: United States, Canada