Randomized Trial of Kamuvudine-9 (K9) in DME
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
• 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.
• Females of childbearing potential must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.
• Males must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.