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
- Conditions
- Wet Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT06556368
- Lead Sponsor
- Kodiak Sciences Inc
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 675
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarcocimab tedromer 5 mg (KSI-301) Tarcocimab tedromer Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks. Tabirafusp tedromer 5 mg (KSI-501) Tabirafusp tedromer 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) Aflibercept 2 mg Aflibercept Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing
- Primary Outcome Measures
Name Time Method Best corrected visual acuity (PCVA Week 48 Mean change in BCVA from Day 1 to Year 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
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 Retina Consultants
🇺🇸Oxnard, 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
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
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
Vitreo Retinal Consultants and Surgeons
🇺🇸Wichita, Kansas, 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
🇺🇸St. Louis Park, Minnesota, United States
Mississippi Retina Associates
🇺🇸Madison, Mississippi, United States
Retina Consultants of Nevada
🇺🇸Henderson, Nevada, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, 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
🇺🇸Wake Forest, North Carolina, United States
Piedmont Retina Specialist
🇺🇸Greensboro, North Carolina, United States
Graystone Eye
🇺🇸Hickory, 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
🇺🇸West Columbia, South Carolina, United States
Charleston Neuroscience Institute, LLC
🇺🇸Ladson, South Carolina, United States
Charleston Neuroscience Institute
🇺🇸Mount Pleasant, South Carolina, United States
Ophthalmology Ltd
🇺🇸Sioux Falls, South Dakota, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Southeastern Retina Associates PC
🇺🇸Knoxville, 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
🇺🇸Plano, Texas, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates, PLLC
🇺🇸Round Rock, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Star Vision Research
🇺🇸Burleson, Texas, United States
Texas Retina Center
🇺🇸Houston, Texas, United States
Retinal Consultants of Houston dba Retina Consultants of Texas
🇺🇸San Antonio, 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