Key Inclusion Criteria
· Age =18 years and < 80 years.
· Type 1 or type 2 diabetes.
· At least one eye with the following:
o Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
o Best-corrected E-ETDRS visual acuity letter score of =74 (approximate Snellen equivalent 20/32 or better).
· If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)
Key Exclusion Criteria
Eye-level exclusion criteria (the eye is ineligible if any of the following is met):
· Current CI-DME based on clinical exam or OCT central subfield thickness (CST)
o Zeiss Cirrus: CST =290 µm in women or = 305 µm in men
o Heidelberg Spectralis: CST =305 µm in women or =320 µm in men
· Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
· History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):
· Decreased renal function, defined as requiring dialysis or central laboratory eGFR value < 45 mL/min/1.73 m2