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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy

In brief

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

Key facts

Study ID

NCT06270836

Run by

Kodiak Sciences Inc

People needed

255

Starts

2024-05-01

Expected to finish

2026-02-13

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 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 screening and confirmed at Day 1; OR
• CST >320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.

You may not qualify if…

• Prior PRP in the Study Eye.
• Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
• Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
• Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
• Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
• 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 to require surgical extraction within 12 months of screening.
• Significant media opacities, including cataract, in the Study Eye that might interfere 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 surgical intervention 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 the study.
• History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
• Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
• Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
• Other protocol-specified exclusion criteria may apply.

Where it is running

• Retina Associates SW — Tucson, Arizona, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Global Research Management, Inc. - Lugene Eye Institute — Glendale, California, United States
• Retinal Consultants Medical Group, Inc. — Modesto, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Retinal Consultants Medical Group, Inc. — Sacramento, California, United States
• Retina Group of New England, PC — Waterford, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Springfield Clinic LLP — Springfield, Illinois, United States
• Associated Vitreoretinal and Uveitis Consultants — Carmel, Indiana, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Retina Consultants of Nevada — Henderson, Nevada, United States
• Envision Ocular, LLC — Bloomfield, New Jersey, United States
• Asheville Eye Associates — Asheville, North Carolina, United States
• North Carolina Retina Associates (Cary) — Cary, North Carolina, United States
• North Carolina Retina Associates (Wake Forest) — Wake Forest, North Carolina, United States
• Cascade Medical Research Institute — Springfield, Oregon, United States
• Erie Retina Research — Erie, Pennsylvania, United States
• Charleston Neuroscience Institute — Charleston, South Carolina, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Southeastern Retina Associates PC — Knoxville, Tennessee, United States
• Retina Research Institute of Texas — Abilene, Texas, United States

Full record on ClinicalTrials.gov

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