NCT00576459

Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema

A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	0.59 mg fluocinolone acetonide intravitreal implant	0.59 mg
DRUG	2.1 mg fluocinolone acetonide intravitreal implant	2.1 mg
PROCEDURE	standard of care laser photocoagulation	standard of care laser photocoagulation

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-06-01
• Completion: 2006-07-01
• First posted: 2007-12-19
• Last updated: 2011-12-08

Locations

2 sites across 2 countries: China, India