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 (DAYBREAK)

April 23, 2026 updated by: Kodiak Sciences Inc

A 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)

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

675

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other Names:
  • KSI-301
Experimental: 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
Other Names:
  • KSI-501
Active Comparator: 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
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity (BCVA)
Time Frame: Week 48
Mean change in BCVA from Day 1 to Year 1
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kodiak Sciences Inc

Investigators

  • Study Director: Pablo Velazquez-Martin, MD, Kodiak Sciences Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS301P109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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