Clinical trial NCT02302079 (phase 2, status: completed)
Conditions: diabetes mellitus, diabetic macular edema
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9, E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513
Drugs: asp8232, ranibizumab, placebo
SMILES: CN\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have a documented diagnosis of type 1 or type 2 diabetes mellitus and a
             glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Screening

          -  Subject has definite retinal thickening due to diffuse diabetic macular edema (DME)
             involving the central macula based on evaluating investigator's clinical evaluation
             and demonstrated by spectral domain-optical coherence tomography (SD-OCT)

          -  Subject has central subfield thickness (CST) of at least 375 μm by SD-OCT with
             presence of intraretinal and/or subretinal fluid at screening visit and at the
             randomization visit

          -  Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual
             acuity (BCVA) letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening
             visit

        Exclusion Criteria:

          -  Subject's study eye has macular edema considered to be due to a cause other than DME

          -  Subject's study eye has a decrease in BCVA due to causes other than DME that is likely
             to be decreasing BCVA by 3 lines or more

          -  Subject's study eye has significant macular ischemia as shown on angiography

          -  Subject's study eye has any other ocular disease that may cause substantial reduction
             in BCVA

          -  Subject has active peri-ocular or ocular infection

          -  Subject's study eye has a history of non-infectious uveitis

          -  Subject's study eye has high myopia (-8 diopter or more correction)

          -  Subject's study eye has a history of prior pars plana vitrectomy

          -  Subject's study eye has a history of any ocular surgery within 3 months prior to Day 1

          -  Subject's study eye has a history of YAG capsulotomy within 3 months prior to Day 1

          -  Subject's study eye has a history of panretinal scatter photocoagulation (PRP) or
             focal laser within 3 months prior to Day 1 or anticipated need for PRP during the
             course of the study through the Week 12 visit

          -  Subject's study eye has a history of prior IVT, subtenon, or periocular, non-sustained
             release, steroid therapy within 3 months prior to Day 1

          -  Subject's study eye has a history of intravitreal sustained release dexamethasone
             therapy within 6 months prior to Day 1.

          -  Subject's study eye has a history of intravitreal sustained release fluocinolone
             within 3 years prior to Day 1.

          -  Subject's study eye has a history of prior treatment for DME with IVT anti-vascular
             endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

          -  Subject has a history of prior treatment with any other (than previously listed)
             approved treatment which is not labeled for DME within 1 year prior to Day 1

          -  Subject's study eye has high-risk proliferative diabetic retinopathy (PDR)

          -  Subject has uncontrolled glaucoma

          -  Subject has media clarity, papillary constriction (i.e., senile miosis), or subject
             lacks cooperation that would interfere with any study procedures, evaluations or
             interpretation of data