Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).
• BCVA of ≥ 24 and ≤ 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400 Snellen equivalent)
• Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral hypoglycemic agents for the treatment of diabetes
• DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and/or spectral domain-optical coherence tomography (SD-OCT)
• Mean foveal thickness of at least 325 µm by SD-OCT
• Ability and willingness to comply with the treatment and follow up procedures
• Ability to understand and sign the informed consent form
• Intraocular pressure of ≤ 21 mm Hg on 2 or fewer IOP lowering medications