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

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.

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