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.