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

Inclusion Criteria: * Subjects with type 1 or 2 diabetes. * Subjects with clinically significant macular edema as defined by the ETDRS. * A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart. * Subjects with laser treatment status/history as follows: \[1\] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, \[2\] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula. * The subject's ocular media had to be sufficiently clear to allow for quality fundus photography. * If aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening. * Subjects had to be males or non-pregnant females of at least 18 years. * Subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an Informed Consent Form. Exclusion Criteria: * Subjects who have had previous grid macular photocoagulation for diffuse macular edema. * Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy. * History of or current retinal detachment requiring surgical treatment or a scleral buckle. * Diabetic Retinopathy that required immediate PRP. * Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.). * Glaucoma, or history of glaucoma in either the study eye or the fellow eye. * Ocular hypertension, or history of ocular hypertension requiring IOP lowering treatment. * A media opacity that precludes visualization and/or diagnosis of the status of the eye. * Concurrent coumadin therapy or known bleeding diathesis. * Subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease. * Concurrent treatment with a new investigational drug. * Subjects with a best-corrected visual acuity worse than +1.0 logMAR (20/200 or 35 ETDRS letters) in the fellow eye. * Pregnant or lactating females. * Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy. * History of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device. * Subjects with photophobia that will preclude the ability to do fundus evaluations.