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

Last updated: March 26, 2025
Sponsor: Kodiak Sciences Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Tabirafusp tedromer

Aflibercept

Tarcocimab tedromer

Clinical Study ID

NCT06556368
KS301P109
  • Ages > 50
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD,including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatousproliferations (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

Exclusion Criteria:

  • BCVA of hand motion or worse in the non-Study Eye or non-physical presence of anon-Study Eye (i.e., monocular)

  • Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center ofthe Study Eye at Screening

Study Design

Total Participants: 675
Treatment Group(s): 3
Primary Treatment: Tabirafusp tedromer
Phase: 3
Study Start date:
August 23, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Emanuelli Research & Development Center, LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Associated Retina Consultants

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Retina Associates SW

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Global Research Management, Inc. - Lugene Eye Institute

    Glendale, California 91204
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group, Inc.

    Modesto, California 95356
    United States

    Active - Recruiting

  • California Retina Consultants

    Oxnard, California 93036
    United States

    Active - Recruiting

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California 91107
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group Inc

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Retina Group of New England, PC

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Blue Ocean Clinical Research

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Retina Group of Florida

    Ft. Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Retina Group of Florida

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Associated Vitreoretinal and Uveitis Consultants LLC

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Midwest Eye Institute

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Vitreo Retinal Consultants and Surgeons

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Retina Consultants of Minnesota

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Retina Consultants of Minnesota

    St. Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • Retina Consultants of Nevada

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • Long Island Vitreoretinal Consultants

    Hauppauge, New York 11788
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Retina Associates of Western NY

    Rochester, New York 14620
    United States

    Active - Recruiting

  • Asheville Eye Associates

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • North Carolina Retina Associates

    Cary, North Carolina 27511
    United States

    Active - Recruiting

  • Piedmont Retina Specialist

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Graystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • North Carolina Retina Associates

    Wake Forest, North Carolina 27587
    United States

    Active - Recruiting

  • Western Carolina Clinical Research, LLC

    Winston Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Western Carolina Clinical Research, LLC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Retina Northwest

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Cascade Medical Research Institute

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Vision Research Solutions

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Vision Research Solutions PLLC

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Palmetto Retina Center

    Aiken, South Carolina 29802
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute, LLC

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute, LLC

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Palmetto Retina Center

    Florence, South Carolina 29501
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute, LLC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Southeastern Retina Associates PC

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Panhandle Eye Group, LLP. - Southwest Retina Specialists

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Austin Retina Associates, PLLC

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Beaumont, Texas 77707
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Star Vision Research

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Retina Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Texas Retina Associates

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Austin Retina Associates, PLLC

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Retinal Consultants of Houston dba Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Schertz, Texas 78154
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Pacific Northwest Retina

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin 54403
    United States

    Active - Recruiting

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