Fenofibrate for Prevention of DR Worsening

Key Inclusion Criteria

• Age ≥18 years and < 80 years.

• Type 1 or type 2 diabetes.

• At least one eye with the following:

• Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.

• Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study.

• 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)

• Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men

• 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