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

NCT06556368 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: KS301P109
• Study Type: interventional
• Target: 675
• Locations: 2 countries
• Sites: 72

Brief 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)

Conditions

Wet Age-related Macular Degeneration

Keywords

Wet AMD; KSI-301; KSI-501; Tarcocimab; Tabirafusp; Aflibercept; Antibody biopolymer conjugate; AMD; Anti-VEGF; Vascular endothelial growth factor; Kodiak Sciences

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity (BCVA)

  Mean change in BCVA from Day 1 to Year 1

  Week 48

Study Arms (3)

Tarcocimab tedromer 5 mg (KSI-301)

EXPERIMENTAL

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

Tabirafusp tedromer 5 mg (KSI-501)

EXPERIMENTAL

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

Aflibercept 2 mg

ACTIVE COMPARATOR

Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Drug: Aflibercept

Interventions

Tarcocimab tedromer DRUG

Intravitreal injection

Also known as: KSI-301

Tarcocimab tedromer 5 mg (KSI-301)

Tabirafusp tedromer DRUG

Intravitreal injection

Also known as: KSI-501

Tabirafusp tedromer 5 mg (KSI-501)

Aflibercept DRUG

Intravitreal injection

Also known as: Eylea

Aflibercept 2 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kodiak Sciences Inc: lead

Study Sites (72)

Associated Retina Consultants

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Retina Associates SW

Tucson, Arizona, 85704, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Global Research Management, Inc. - Lugene Eye Institute

Glendale, California, 91204, United States

Location

Retinal Consultants Medical Group, Inc.

Modesto, California, 95356, United States

Location

California Eye Specialists Medical Group, Inc.

Pasadena, California, 91107, United States

Location

California Eye Specialists Medical Group, Inc.

Redlands, California, 92373, United States

Location

Retinal Consultants Medical Group Inc

Sacramento, California, 95825, United States

Location

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Blue Ocean Clinical Research

Clearwater, Florida, 33761, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Retina Group of Florida

Sarasota, Florida, 34232, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Retina Associates, Ltd

Elmhurst, Illinois, 60126, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Associated Vitreoretinal and Uveitis Consultants LLC

Carmel, Indiana, 46032, United States

Location

Midwest Eye Institute

Carmel, Indiana, 46290, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

Location

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Mississippi Retina Associates

Madison, Mississippi, 39110, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Retina Consultants of Nevada

Henderson, Nevada, 89052, United States

Location

Long Island Vitreoretinal Consultants

Hauppauge, New York, 11788, United States

Location

Retina Vitreous Surgeons of CNY PC

Liverpool, New York, 13088, United States

Location

Retina Associates of Western NY

Rochester, New York, 14620, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803, United States

Location

North Carolina Retina Associates

Cary, North Carolina, 27511, United States

Location

Piedmont Retina Specialist

Greensboro, North Carolina, 27401, United States

Location

Graystone Eye

Hickory, North Carolina, 28602, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Western Carolina Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Retina Northwest

Portland, Oregon, 97210, United States

Location

Cascade Medical Research Institute

Springfield, Oregon, 97477, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Vision Research Solutions PLLC

Philadelphia, Pennsylvania, 19141, United States

Location

Palmetto Retina Center

Aiken, South Carolina, 29802, United States

Location

Charleston Neuroscience Institute, LLC

Beaufort, South Carolina, 29902, United States

Location

Charleston Neuroscience Institute, LLC

Charleston, South Carolina, 29414, United States

Location

Charleston Neuroscience Institute, LLC

Ladson, South Carolina, 29456, United States

Location

Charleston Neuroscience Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Ophthalmology Ltd

Sioux Falls, South Dakota, 57108, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Panhandle Eye Group, LLP. - Southwest Retina Specialists

Amarillo, Texas, 79106, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Austin Retina Associates, PLLC

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Star Vision Research

Burleson, Texas, 76028, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Texas Retina Center

Houston, Texas, 77030, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Texas Retina Associates

Plano, Texas, 75075, United States

Location

Austin Retina Associates, PLLC

Round Rock, Texas, 78681, United States

Location

Retinal Consultants of Houston dba Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

Schertz, Texas, 78154, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

Eye Clinic of Wisconsin

Wausau, Wisconsin, 54403, United States

Location

Emanuelli Research & Development Center, LLC

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Pablo Velazquez-Martin, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 16, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (71); PR (1)