Clinical trial NCT00676559 (phase 1, status: withdrawn)
Conditions: diabetic macular edema
ICD codes: E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513
Drugs: efalizumab, ranibizumab
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O
Reason stopped: 
    unrelated serious adverse events involving one of the proposed medications
  
Eligibility criteria:

        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