Evaluation of Tonabersat for DME (AN)

Key Inclusion Criteria Adults with type 1 or 2 diabetes mellitus At least one eye with: Best corrected E-ETDRS visual acuity letter score ≥ 79 (i.e., 20/25 or better) Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: <75 μm, 75 μm to <175 μm, ≥175 μm Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT Key Exclusion Criteria Macular edema is considered to be due to a cause other than DME Major ocular surgery within prior 4 months, or anticipated after randomization History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 prior anti-VEGF injections total Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period Any history of vitrectomy Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization History of chronic renal failure requiring dialysis or kidney transplant History of moderate to severe hepatic impairment, including known liver function test (LFT) values > 3x's the upper limit of normal