Kamuvudine-9 (K9) in Diabetic Macular Edema
Trial Parameters
Brief Summary
The objectives of this investigation are to assess: 1. whether oral K9 is safe in subjects with DME, and 2. whether oral K9 improves BCVA compared to oral placebo
Eligibility Criteria
Inclusion Criteria: * Aged 18 years or older. * 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 evident on fundus photographs, fluorescein angiograms, or spectral domain-optical coherence tomography (SD-OCT) * HbA1c of ≤12% at screening. * BCVA of ≥ 24 and ≤ 68 letters (20/50 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). * Mean central subfield thickness (CST) of at least 325 µm by SD-OCT. * Intraocular pressure of ≤ 21 mm Hg on 2 or fewer IOP lowering medications. * Capable of providing informed consent. * Capable and willing to follow study protocol. * F