Clinical trial NCT06556368: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 675
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Best corrected visual acuity (PCVA
timeFrame: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Tucson
country: United States
facility: Retina Associates SW
state: Arizona
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Glendale
country: United States
facility: Global Research Management, Inc. - Lugene Eye Institute
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc.
state: California
city: Redlands
country: United States
facility: California Eye Specialists Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group Inc
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Ft. Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Sarasota
country: United States
facility: Retina Group of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Elmhurst
country: United States
facility: Retina Associates, Ltd
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Carmel
country: United States
facility: Associated Vitreoretinal and Uveitis Consultants LLC
state: Indiana
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Wichita
country: United States
facility: Vitreo Retinal Consultants and Surgeons
state: Kansas
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: St. Louis Park
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: St. Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Henderson
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of CNY PC
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Cary
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Greensboro
country: United States
facility: Piedmont Retina Specialist
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Western Carolina Clinical Research, LLC
state: North Carolina
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Vision Research Solutions PLLC
state: Pennsylvania
city: Aiken
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Beaufort
country: United States
facility: Charleston Neuroscience Institute, LLC
state: South Carolina
city: Charleston
country: United States
facility: Charleston Neuroscience Institute, LLC
state: South Carolina
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute, LLC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Ophthalmology Ltd
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Knoxville
country: United States
facility: Southeastern Retina Associates PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Amarillo
country: United States
facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates, PLLC
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Burleson
country: United States
facility: Star Vision Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Texas Retina Center
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Plano
country: United States
facility: Texas Retina Associates
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates, PLLC
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Houston dba Retina Consultants of Texas
state: Texas
city: Schertz
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center, LLC
Study officials:
affiliation: Kodiak Sciences Inc
name: Pablo Velazquez-Martin, MD
role: STUDY_DIRECTOR
References: