A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
NCT ID: NCT06270836
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
255 participants
INTERVENTIONAL
2024-05-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tarcocimab 5 mg (Treatment Group A)
Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44.
Tarcocimab
Intravitreal injection
Treatment Group B
Sham injection on the same schedule as Treatment Group A
Sham injection
The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
Interventions
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Tarcocimab
Intravitreal injection
Sham injection
The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Kodiak Sciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Pablo Velazquez-Martin, MD
Role: STUDY_DIRECTOR
Kodiak Sciences Inc
Locations
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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
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
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, United States
Austin Retina Associates, PLLC (Austin)
Austin, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Retina Consultants of Texas (Bellaire)
Bellaire, Texas, United States
Star Vision Research
Burleson, Texas, United States
Retina Consultants of Texas (Katy)
Katy, Texas, United States
Texas Retina Associates
Plano, Texas, United States
Austin Retina Associates, PLLC (Round Rock)
Round Rock, Texas, United States
Retina Consultants of Texas (San Antonio)
San Antonio, Texas, United States
Retina Consultants of Texas (Woodlands)
The Woodlands, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Pacific Northwest Retina (Bellevue)
Bellevue, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Emanuelli Research & Development Center, LLC
Arecibo, , Puerto Rico
Countries
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Other Identifiers
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KS301P108
Identifier Type: -
Identifier Source: org_study_id
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