NCT00502541

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	fluocinolone acetonide	fluocinolone acetonide 0.59 mg intravitreal implant
PROCEDURE	Standard of Care	Repeat macular grid laser or observation

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2007-07-17
• Last updated: 2013-11-28