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
NCT ID: NCT06556368
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
675 participants
INTERVENTIONAL
2024-08-23
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
NCT06270836
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089
A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
NCT06961370
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
NCT05893537
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
NCT06550011
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Tarcocimab tedromer
Intravitreal injection
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)
Tabirafusp tedromer
Intravitreal injection
Aflibercept 2 mg
Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing
Aflibercept
Intravitreal injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tarcocimab tedromer
Intravitreal injection
Tabirafusp tedromer
Intravitreal injection
Aflibercept
Intravitreal injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kodiak Sciences Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pablo Velazquez-Martin, MD
Role: STUDY_DIRECTOR
Kodiak Sciences Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Associated Retina Consultants
Gilbert, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
Retina Associates SW
Tucson, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Global Research Management, Inc. - Lugene Eye Institute
Glendale, California, United States
Retinal Consultants Medical Group, Inc.
Modesto, California, United States
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Retina Group of Florida
Sarasota, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Retina Associates, Ltd
Elmhurst, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, United States
Midwest Eye Institute
Carmel, Indiana, United States
The Retina Care Center
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Minnesota
Edina, Minnesota, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States
Mississippi Retina Associates
Madison, Mississippi, United States
The Retina Institute
St Louis, Missouri, United States
Retina Consultants of Nevada
Henderson, Nevada, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, United States
Retina Associates of Western NY
Rochester, New York, United States
Asheville Eye Associates
Asheville, North Carolina, United States
North Carolina Retina Associates
Cary, North Carolina, United States
Piedmont Retina Specialist
Greensboro, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Western Carolina Clinical Research, LLC
Winston-Salem, North Carolina, United States
Retina Northwest
Portland, Oregon, United States
Cascade Medical Research Institute
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Vision Research Solutions PLLC
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
Aiken, South Carolina, United States
Charleston Neuroscience Institute, LLC
Beaufort, South Carolina, United States
Charleston Neuroscience Institute, LLC
Charleston, South Carolina, United States
Charleston Neuroscience Institute, LLC
Ladson, South Carolina, United States
Charleston Neuroscience Institute
Mt. Pleasant, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Ophthalmology Ltd
Sioux Falls, South Dakota, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates, PLLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Star Vision Research
Burleson, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Texas Retina Center
Houston, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Texas Retina Associates
Plano, Texas, United States
Austin Retina Associates, PLLC
Round Rock, Texas, United States
Retinal Consultants of Houston dba Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas
Schertz, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Pacific Northwest Retina
Bellevue, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Emanuelli Research & Development Center, LLC
Arecibo, Puerto Rico, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KS301P109
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.