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Wet Age-related Macular DegenerationPhase 3DAYBREAKNCT06556368

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

A Phase 3 study testing Tarcocimab tedromer, Tabirafusp tedromer and Aflibercept in people with Wet Age-related Macular Degeneration, run by Kodiak Sciences Inc at 72 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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) Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
Tarcocimab tedromer, Tabirafusp tedromer and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
667 participants
Where
72 sitesin 2 countries
Study dates
23 Aug 2024to Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

72 sites in 2 countries.

72 sites in 2 countries

United States71 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Palmetto Retina Center

    Aiken, South Carolina, 29802

  • Panhandle Eye Group, LLP. - Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Asheville Eye Associates

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates, PLLC

    Austin, Texas, 78705

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Charleston Neuroscience Institute, LLC

    Beaufort, South Carolina, 29902

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Star Vision Research

    Burleson, Texas, 76028

  • Associated Vitreoretinal and Uveitis Consultants LLC

    Carmel, Indiana, 46032

  • Midwest Eye Institute

    Carmel, Indiana, 46290

  • North Carolina Retina Associates

    Cary, North Carolina, 27511

  • Charleston Neuroscience Institute, LLC

    Charleston, South Carolina, 29414

  • Blue Ocean Clinical Research

    Clearwater, Florida, 33761

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • Retina Associates, Ltd

    Elmhurst, Illinois, 60126

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Texas Retina Associates

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Associated Retina Consultants

    Gilbert, Arizona, 85297

  • Global Research Management, Inc. - Lugene Eye Institute

    Glendale, California, 91204

  • Piedmont Retina Specialist

    Greensboro, North Carolina, 27401

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Long Island Vitreoretinal Consultants

    Hauppauge, New York, 11788

  • Retina Consultants of Nevada

    Henderson, Nevada, 89052

  • Graystone Eye

    Hickory, North Carolina, 28602

  • Texas Retina Center

    Houston, Texas, 77030

  • Retina Consultants of Texas

    Katy, Texas, 77494

  • Charleston Neuroscience Institute, LLC

    Ladson, South Carolina, 29456

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York, 13088

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

  • Retinal Consultants Medical Group, Inc.

    Modesto, California, 95356

  • Charleston Neuroscience Institute

    Mt. Pleasant, South Carolina, 29464

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California, 91107

  • Vision Research Solutions PLLC

    Philadelphia, Pennsylvania, 19141

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Texas Retina Associates

    Plano, Texas, 75075

  • Retina Northwest

    Portland, Oregon, 97210

  • California Eye Specialists Medical Group, Inc.

    Redlands, California, 92373

  • Retina Associates of Western NY

    Rochester, New York, 14620

  • Austin Retina Associates, PLLC

    Round Rock, Texas, 78681

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

  • Retinal Consultants of Houston dba Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Group of Florida

    Sarasota, Florida, 34232

  • Retina Consultants of Texas

    Schertz, Texas, 78154

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

  • Ophthalmology Ltd

    Sioux Falls, South Dakota, 57108

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Cascade Medical Research Institute

    Springfield, Oregon, 97477

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Retina Associates SW

    Tucson, Arizona, 85704

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Western Carolina Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research & Development Center, LLC

    Arecibo, Puerto Rico, 00612

Other trials in Puerto Rico

About this study

Official title: 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)

Being tested
Tarcocimab tedromer, Tabirafusp tedromer, Aflibercept
Keywords
Wet AMD, KSI-301, KSI-501, Tarcocimab, Tabirafusp, Aflibercept, Antibody biopolymer conjugate, AMD, Anti-VEGF, Vascular endothelial growth factor, Kodiak Sciences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tarcocimab tedromerDrug

    Also called KSI-301

    Intravitreal injection

  • Tabirafusp tedromerDrug

    Also called KSI-501

    Intravitreal injection

  • AfliberceptDrug

    Also called Eylea

    Intravitreal injection

Study groups in NCT06556368
Study groupRoleWhat they receive
Tarcocimab tedromer 5 mg (KSI-301)ExperimentalIntravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
Receives: Drug: Tarcocimab tedromer
Tabirafusp tedromer 5 mg (KSI-501)ExperimentalIntravitreal 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)
Receives: Drug: Tabirafusp tedromer
Aflibercept 2 mgActive comparatorIntravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best corrected visual acuity (BCVA)

    Mean change in BCVA from Day 1 to Year 1

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start23 Aug 2024
  3. Primary completion2 Sep 2026
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556368
Sponsor's protocol ID
KS301P109
Acronym
DAYBREAK
Status last verified
Oct 2026
First submitted
12 Aug 2024
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarcocimab tedromer, Tabirafusp tedromer and Aflibercept in people with Wet Age-related Macular Degeneration, run by Kodiak Sciences Inc at 72 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best corrected visual acuity (BCVA) (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06556368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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