Clinical trial NCT01982435 (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, ranibizumab
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O, 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:

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

               -  Age > 18 years

               -  ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye

               -  Willing, committed, and able to return for ALL clinic visits and complete all
                  study related procedures

               -  At least 6 previous bevacizumab injections for diabetic macular edema in the last
                  12 months in the study eye.

               -  At least 2 bevacizumab injections within 10 weeks and the most recent bevacizumab
                  injection within 6 weeks of baseline study visits in the study eye.

               -  Persistent foveal-involving diabetic macular edema based on presence of
                  intraretinal and/or subretinal fluid by SDOCT in the foveal center at study entry
                  in the study eye.

        Exclusion Criteria:

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

          -  Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD (intrauterine device), or contraceptive hormone implant
             or patch.

          -  Intravitreal steroid or periocular steroid treatment within 3 months of study entry in
             the study eye.

          -  Focal/grid laser photocoagulation treatment within 3 months of study entry in the
             study eye.

          -  Panretinal photocoagulation treatment within 3 months of study entry in the study eye.

          -  Prior vitrectomy in the study eye

          -  History of retinal detachment in the study eye

          -  Prior trabeculectomy or other filtration surgery in the study eye

          -  Active intraocular inflammation in either eye

          -  Active ocular or periocular infection in either eye

          -  Active scleritis or episcleritis in either eye

          -  History of any other retinal vascular disease (e.g., retinal vein occlusion, retinal
             artery occlusion) in the study eye.

          -  Coexistent retinal disease other than diabetic retinopathy (e.g., AMD (age related
             macular degeneration), inherited retinal disease) in the study eye.

          -  Intraocular surgery within 3 months of study entry in the study eye.

          -  History of corneal transplant or corneal dystrophy in the study eye.

          -  Significant media opacities in study eye which may interfere with visual acuity in the
             study eye.

          -  Participation as a subject in any clinical study within 3 months of study entry.

          -  History of allergy to topical iodine

          -  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