A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (Protocol AN)
This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
• Adults with type 1 or 2 diabetes mellitus
• At least one eye with:
‣ Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 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