Clinical Trials

Key Inclusion Criteria

1. Adults with type 1 or 2 diabetes mellitus
2. At least one eye with:

* Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better)
* Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT
* Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males
* Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males

* Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: \<75 ?m, 75 ?m to \<175 ?m, ≥175 ?m
3. Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT

Key Exclusion Criteria

* Macular edema is considered to be due to a cause other than DME
* Major ocular surgery within prior 4 months, or anticipated after randomization
* History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 anti-VEGF injections within prior 3 years
* Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period
* Any history of vitrectomy
* Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization
* History of chronic renal failure requiring dialysis or kidney transplant
* History of moderate to severe hepatic impairment, including known liver function test (LFT) values \> 3x's the upper limit of normal

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/26/2024. Questions regarding updates should be directed to the study team contact.