A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)

Inclusion Criteria:

• Signed informed consent prior to participation in the study.

• Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.

• DR in the Study Eye (DRSS as determined by the reading center based on color fundusphotographs), who have not previously received intravitreal medications for DR orDME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for atleast 6 months per the Investigator.

• CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screeningand confirmed at Day 1; OR

• CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye atscreening and confirmed at Day 1.

Exclusion Criteria:

• Prior PRP in the Study Eye.

• Current anterior segment neovascularization (ASNV), vitreous hemorrhage, ortractional retinal detachment in the Study Eye.

• Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within thelast twelve (12) months prior to Day 1.

• Prior intravitreal or periocular steroid in the Study Eye for DR or DME within thelast twelve (12) months prior to Day 1.

• Prior use of an investigational intravitreal treatment for DR or DME in the StudyEye.

• History of vitreoretinal surgery in the Study Eye.

• History of uveitis in either eye.

• Cataract in the Study Eye that in the judgment of the Investigator is expected torequire surgical extraction within 12 months of screening.

• Significant media opacities, including cataract, in the Study Eye that mightinterfere with visual acuity, assessment of safety, OCT, or FP.

• Any history or evidence of a concurrent ocular condition present in the Study Eye,that in the opinion of the Investigator could require either medical or surgicalintervention or alter visual acuity during the study.

• Active or suspected ocular or periocular infection or inflammation.

• Women who are pregnant or lactating or intending to become pregnant during thestudy.

• History of a medical condition that, in the judgment of the Investigator, wouldpreclude scheduled study visits, completion of the study, or a safe administrationof investigational product.

• Recent history (within the 6 months prior to screening) of myocardial infarction,stroke, transient ischemic attack, acute congestive heart failure or any acutecoronary event.

• Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolicvalue ≥ 100 mmHg while at rest.

• Other protocol-specified exclusion criteria may apply.