NCT00490815

Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Alimera Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the pharmacokinetics, 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

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-09-01
• Completion: 2011-04-01
• First posted: 2007-06-25
• Last updated: 2014-02-13
• Results posted: 2014-02-13

Locations

1 site across 1 country: United States