Inclusion Criteria:

• Subjects will be eligible if the following criteria are met:

  • Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991)
  • Retinal thickening within 500 mm of the center of the fovea
  • Hard exudates within 500 mm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500um limit)
  • An area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 21 years
  • Visual acuity < 20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam
  • Retinal thickness on OCT measuring 250 microns or more in the central subfield or 350 microns of more in any non-central subfield
  • Media clarity and pupillary dilatation, patient cooperation, and adequate fundus photographs and OCT will be obtainable
  • No other ocular conditions that could cause macular edema will be present

Exclusion Criteria:

• Subjects who meet any of the following criteria will be excluded from this study:

  • Other causes of macular edema will be present
  • Intraocular pressures exceed 25 mm Hg
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin
  • Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
  • Pregnancy or lactation (evidenced by Early Pregnancy Test (EPT) over the counter test)
  • Current treatment of a systemic infection
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
  • History of recurrent significant infections or bacterial infections

  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either

    • Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
    • If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Concurrent ocular disease associated with choroidal neovascularization to include but not limited to presumed ocular Histoplasmosis, high myopia, or macular degeneration
  • Prior/Concomitant Treatment
  • Patient will not have had panretinal photocoagulation treatment within 4 months
  • Grid/focal laser within 2 months of randomization
  • Subtenon steroid in study eye within 6 months
  • Treatment with systemic steroid currently or within the last 4 weeks
  • IVTA within 3 months
  • Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
  • Prior participation in a Genentech ranibizumab clinical trial
  • Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab)
  • Concurrent use of systemic anti-VEGF agents
  • Previous use of Macugen in study eye