Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Fluocinolone Acetonide

Criteria

Inclusion Criteria:

• Males and nonpregnant females at least 18 years of age, with DME in the study eye

• Edema must involve fixation and be at least 1 disc area in size

• Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye

• The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study

• Ability and willingness to comply with treatment and follow-up

• Ability to understand and sign the Informed Consent form

Exclusion Criteria:

• Pregnant, lactating females

• Allergy to fluocinolone acetonide or any component of the delivery system

• Any disease or condition that would preclude study treatment or follow up

• Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).

• History of uncontrolled IOP within the last 12 months