A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Kodiak Sciences Inc
Sponsor
Kodiak Sciences Inc
Information Provided by (Responsible Party)
Kodiak Sciences Inc
Clinicaltrials.gov Identifier
NCT06556368
Other Study ID Numbers:
KS301P109
First Submitted
August 11, 2024
First Posted
August 15, 2024
Last Update Posted
April 28, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Wet Age-related Macular Degeneration
Drug: Tarcocimab tedromerDrug: Tabirafusp tedromerDrug: Aflibercept

Study Design

Study TypeInterventional
Actual Enrollment675 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
Study Start DateAugust 22, 2024
Actual Primary Completion Date2mos 3w from now
Actual Study Completion Date1yr 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Tarcocimab tedromer 5 mg (KSI-301)
Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
Drug: Tarcocimab tedromer
Intravitreal injection
Tabirafusp tedromer 5 mg (KSI-501)
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
Drug: Tabirafusp tedromer
Intravitreal injection
Aflibercept 2 mg
Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing
Drug: Aflibercept
Intravitreal injection

Outcome Measures

Primary Outcome Measures
  1. Best corrected visual acuity (BCVA)
    Mean change in BCVA from Day 1 to Year 1

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening
BCVA ETDRS score between 78 and 25 letters (Snellen equivalent \~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1.
Capable of giving signed informed consent.
Exclusion Criteria
BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening

Contacts and Locations

Sponsors and CollaboratorsKodiak Sciences Inc
Locations
Associated Retina Consultants | Gilbert Arizona, United States, 85297Associated Retina Consultants | Phoenix Arizona, United States, 85020Retina Macula Institute of Arizona | Scottsdale Arizona, United States, 85255Retina Associates SW | Tucson Arizona, United States, 85704Retina Consultants of Orange County | Fullerton California, United States, 92835Global Research Management, Inc. - Lugene Eye Institute | Glendale California, United States, 91204Retinal Consultants Medical Group, Inc. | Modesto California, United States, 95356California Eye Specialists Medical Group, Inc. | Pasadena California, United States, 91107California Eye Specialists Medical Group, Inc. | Redlands California, United States, 92373Retinal Consultants Medical Group Inc | Sacramento California, United States, 95825Retina Consultants of Southern Colorado | Colorado Springs Colorado, United States, 80909Retina Group of New England, PC | Waterford Connecticut, United States, 06385Blue Ocean Clinical Research | Clearwater Florida, United States, 33761Retina Group of Florida | Fort Lauderdale Florida, United States, 33308National Ophthalmic Research Institute | Fort Myers Florida, United States, 33912Retina Group of Florida | Sarasota Florida, United States, 34232Center for Retina and Macular Disease | Winter Haven Florida, United States, 33880Southeast Retina Center | Augusta Georgia, United States, 30909Retina Associates, Ltd | Elmhurst Illinois, United States, 60126Illinois Retina Associates | Oak Park Illinois, United States, 60304Associated Vitreoretinal and Uveitis Consultants LLC | Carmel Indiana, United States, 46032Midwest Eye Institute | Carmel Indiana, United States, 46290The Retina Care Center | Baltimore Maryland, United States, 21209Cumberland Valley Retina Consultants | Hagerstown Maryland, United States, 21740Ophthalmic Consultants of Boston | Boston Massachusetts, United States, 02114Retina Consultants of Minnesota | Edina Minnesota, United States, 55435Retina Consultants of Minnesota | Saint Louis Park Minnesota, United States, 55416Mississippi Retina Associates | Madison Mississippi, United States, 39110The Retina Institute | St Louis Missouri, United States, 63128Retina Consultants of Nevada | Henderson Nevada, United States, 89052Long Island Vitreoretinal Consultants | Hauppauge New York, United States, 11788Retina Vitreous Surgeons of CNY PC | Liverpool New York, United States, 13088Retina Associates of Western NY | Rochester New York, United States, 14620Asheville Eye Associates | Asheville North Carolina, United States, 28803North Carolina Retina Associates | Cary North Carolina, United States, 27511Piedmont Retina Specialist | Greensboro North Carolina, United States, 27401Graystone Eye | Hickory North Carolina, United States, 28602North Carolina Retina Associates | Wake Forest North Carolina, United States, 27587Western Carolina Clinical Research, LLC | Winston-Salem North Carolina, United States, 27103Retina Northwest | Portland Oregon, United States, 97210Cascade Medical Research Institute | Springfield Oregon, United States, 97477Erie Retina Research | Erie Pennsylvania, United States, 16507Vision Research Solutions PLLC | Philadelphia Pennsylvania, United States, 19141Palmetto Retina Center | Aiken South Carolina, United States, 29802Charleston Neuroscience Institute, LLC | Beaufort South Carolina, United States, 29902Charleston Neuroscience Institute, LLC | Charleston South Carolina, United States, 29414Charleston Neuroscience Institute, LLC | Ladson South Carolina, United States, 29456Charleston Neuroscience Institute | Mt. Pleasant South Carolina, United States, 29464Palmetto Retina Center | West Columbia South Carolina, United States, 29169Ophthalmology Ltd | Sioux Falls South Dakota, United States, 57108Charles Retina Institute | Germantown Tennessee, United States, 38138Retina Research Institute of Texas | Abilene Texas, United States, 79606Panhandle Eye Group, LLP. - Southwest Retina Specialists | Amarillo Texas, United States, 79106Texas Retina Associates | Arlington Texas, United States, 76012Austin Research Center for Retina | Austin Texas, United States, 78705Austin Retina Associates, PLLC | Austin Texas, United States, 78705Retina Consultants of Texas | Bellaire Texas, United States, 77401Star Vision Research | Burleson Texas, United States, 76028Texas Retina Associates | Fort Worth Texas, United States, 76104Texas Retina Center | Houston Texas, United States, 77030Retina Consultants of Texas | Katy Texas, United States, 77494Texas Retina Associates | Plano Texas, United States, 75075Austin Retina Associates, PLLC | Round Rock Texas, United States, 78681Retinal Consultants of Houston dba Retina Consultants of Texas | San Antonio Texas, United States, 78240Retina Consultants of Texas | Schertz Texas, United States, 78154Retina Consultants of Texas | The Woodlands Texas, United States, 77384Strategic Clinical Research Group, LLC | Willow Park Texas, United States, 76087Piedmont Eye Center | Lynchburg Virginia, United States, 24502Pacific Northwest Retina | Bellevue Washington, United States, 98004Spokane Eye Clinical Research | Spokane Washington, United States, 99204Eye Clinic of Wisconsin | Wausau Wisconsin, United States, 54403Emanuelli Research & Development Center, LLC | Arecibo , Puerto Rico, 00612
Investigators
Study Director: Pablo Velazquez-Martin, MD, Kodiak Sciences Inc