Clinical trial NCT01292798 (phase 1/phase 2, status: completed)
Conditions: diabetic macular edema
ICD codes: E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513
Drugs: ranibizumab
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O
Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years

          -  Diagnosis of diabetes mellitus (type 1 or 2)Any one of the following will be
             considered to be sufficient evidence that diabetes is present:Current regular use of
             insulin for treatment of diabetes or current regular use of oral anti-hyperglycemia
             agent for the treatment of diabetes

          -  Clinical evidence of retinal thickening due to macular edema involving the center of
             the macula, associated with diabetic retinopathy.

          -  Previous history of two consecutive intravitreal bevacizumab injections for the
             treatment of diabetic macular edema with documented incomplete resolution of central
             subfield thickening by OCT (consecutive injections administered < 7 weeks apart and
             within the past 12 months).

          -  Central diabetic macular edema present on clinical examination and OCT testing with
             central 1mm subfield thickness greater than 300 microns as measured on SD-OCT.

          -  Visual acuity score greater than or equal to 19 letters (20/400) and less than or
             equal to 73 letters (20/40) by the ETDRS visual acuity protocol.

          -  Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
             testing and retinal photography

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women
             not using adequate contraception.

          -  Participation in another ocular investigation or trial simultaneously

          -  Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)

          -  Any condition that, in the opinion of the investigator, would preclude participation
             in the study (e.g. chronic alcoholism, drug abuse)

          -  Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be
             contributing to the macular edema

          -  An eye that, in the investigator's opinion, has no chance of improving in visual
             acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or
             geographic atrophy)

          -  Presence of another ocular condition that may affect the visual acuity or macular
             edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)

          -  Evidence of neovascularization of the iris or retina

          -  Evidence of central atrophy or fibrosis in the study eye

          -  Presence of substantial cataract, one that might decrease the vision by 3 or more
             lines of vision at sometime during the study.

          -  History of vitreous surgery in the study eye

          -  History of cataract surgery within 6 months of enrollment.

          -  History of YAG capsulotomy within 2 months of enrollment.

          -  Visual acuity <20/400 in the fellow eye

          -  Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.

          -  History of cerebral vascular accident or myocardial infarction within 3 months prior
             to Day 0.