NCT00344968

Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 956 (actual)
• Sponsor: Alimera Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	fluocinolone acetonide	0.5 mg fluocinolone acetonide intravitreal insert
DRUG	Fluocinolone Acetonide	0.2 mg fluocinolone acetonide intravitreal insert
PROCEDURE	Standard of care laser photocoagulation	Laser photocoagulation

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2006-06-27
• Last updated: 2014-05-07
• Results posted: 2014-05-07

Locations

1 site across 1 country: United States