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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
675

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kodiak Sciences Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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