Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study (CAPTURE)

Inclusion Criteria:

• Signed informed consent and authorization of use and disclosure of protected health information
• 18 years of Age
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Serum HbA1c 5.5% within 12 months of randomization
• Retinal thickening (diabetic macular edema) involving the center of the fovea
• Diagnosis must be confirmed by fluorescein angiography and OCT images over 250
• Best corrected visual acuity score in the study eye of 20/40 to 20/320
• If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception.
• If a non-sterile male, commitment to the use of two forms of effective contraception.
• Demonstrate understanding of and ability to perform weekly self sub-cutaneous injections.

Exclusion Criteria:

• Panretinal or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry

• Current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry

  • Proliferative diabetic retinopathy in the study eye, with the exceptions of
  • inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation OR
  • tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
  • Vitreomacular traction or epiretinal membrane in the study eye
  • Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
  • Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-months.
  • Cataract surgery in the study eye within 3 months of study entry; (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
  • History of vitreoretinal surgery in the study eye within 3 months of study entry
  • Uncontrolled glaucoma .
  • Blood pressure exceeding 180/100 (sitting) during the screening period
  • Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin > or = 13%(HbA1c) value
  • Renal failure requiring dialysis or renal transplant
  • Premenopausal women unwilling to commit to adequate contraception
  • History of other diseases or finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
  • International Normalized Ratio (INR) > or = 3.0 (e.g. due to current treatment with warfarin).
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
  • Have a history of hypersensitivity to efalizumab
  • Have a history of ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. Have a history of opportunistic infections.
  • Have the presence or history of malignancy, including lymphoproliferative disorders.
  • Have a history of thrombocytopenia, clinically significant hemolytic anemia, or unexplained anemia
  • Have a platelet count < 100,000 cells/microliter (uL)
  • Inability to comply
  • Patients receiving immunosuppressive agents
  • All acellular, live and live-attenuated vaccines are excluded from 14 days prior to the first dose of efalizumab until a minimum of 4 weeks after the last dose of efalizumab
  • 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