Clinical trial NCT00387582 (phase 2, status: completed)
Conditions: diabetic retinopathy, diabetic macular edema
ICD codes: H35.23, H35.20, H35.21, H35.22, E10.3553, E11.3553, E13.3553, E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513
Drugs: ranibizumab (lucentis)
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O
Eligibility criteria:

        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