En undersøgelse for at evaluere effektiviteten og sikkerheden af Tarcocimab Tedromer og Tabirafusp Tedromer sammenlignet med Aflibercept hos deltagere med neovaskulær (våd) aldersrelateret makuladegeneration (wAMD) - DAGBREAK (DAYBREAK)
3. november 2026 opdateret af: Kodiak Sciences Inc
En prospektiv, randomiseret, dobbeltmasket, aktiv komparator-kontrolleret, multicenter, tre-arm fase 3-undersøgelse til evaluering af effektiviteten og sikkerheden af Intravitreal Tarcocimab Tedromer og Tabirafusp Tedromer sammenlignet med Intravitreal Aflibercept hos deltagere med neovaskulær (våd) alder- relateret makuladegeneration (wAMD)
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)
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
667
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Gilbert, Arizona, Forenede Stater, 85297
- Associated Retina Consultants
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Phoenix, Arizona, Forenede Stater, 85020
- Associated Retina Consultants
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Scottsdale, Arizona, Forenede Stater, 85255
- Retina Macula Institute of Arizona
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Tucson, Arizona, Forenede Stater, 85704
- Retina Associates SW
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California
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Fullerton, California, Forenede Stater, 92835
- Retina Consultants of Orange County
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Glendale, California, Forenede Stater, 91204
- Global Research Management, Inc. - Lugene Eye Institute
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Modesto, California, Forenede Stater, 95356
- Retinal Consultants Medical Group, Inc.
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Pasadena, California, Forenede Stater, 91107
- California Eye Specialists Medical Group, Inc.
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Redlands, California, Forenede Stater, 92373
- California Eye Specialists Medical Group, Inc.
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Sacramento, California, Forenede Stater, 95825
- Retinal Consultants Medical Group Inc
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Retina Consultants of Southern Colorado
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Connecticut
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Waterford, Connecticut, Forenede Stater, 06385
- Retina Group of New England, PC
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Florida
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Clearwater, Florida, Forenede Stater, 33761
- Blue Ocean Clinical Research
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Retina Group of Florida
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Fort Myers, Florida, Forenede Stater, 33912
- National Ophthalmic Research Institute
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Sarasota, Florida, Forenede Stater, 34232
- Retina Group of Florida
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Winter Haven, Florida, Forenede Stater, 33880
- Center for Retina and Macular Disease
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Georgia
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Augusta, Georgia, Forenede Stater, 30909
- Southeast Retina Center
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Illinois
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Elmhurst, Illinois, Forenede Stater, 60126
- Retina Associates, Ltd
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Oak Park, Illinois, Forenede Stater, 60304
- Illinois Retina Associates
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Indiana
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Carmel, Indiana, Forenede Stater, 46290
- Midwest Eye Institute
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Carmel, Indiana, Forenede Stater, 46032
- Associated Vitreoretinal and Uveitis Consultants LLC
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Maryland
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Baltimore, Maryland, Forenede Stater, 21209
- The Retina Care Center
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Hagerstown, Maryland, Forenede Stater, 21740
- Cumberland Valley Retina Consultants
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ophthalmic Consultants of Boston
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Minnesota
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Edina, Minnesota, Forenede Stater, 55435
- Retina Consultants of Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Retina Consultants of Minnesota
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Mississippi
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Madison, Mississippi, Forenede Stater, 39110
- Mississippi Retina Associates
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- The Retina Institute
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Nevada
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Henderson, Nevada, Forenede Stater, 89052
- Retina Consultants of Nevada
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New York
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Hauppauge, New York, Forenede Stater, 11788
- Long Island Vitreoretinal Consultants
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Liverpool, New York, Forenede Stater, 13088
- Retina Vitreous Surgeons of CNY PC
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Rochester, New York, Forenede Stater, 14620
- Retina Associates of Western NY
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Asheville Eye Associates
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Cary, North Carolina, Forenede Stater, 27511
- North Carolina Retina Associates
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Greensboro, North Carolina, Forenede Stater, 27401
- Piedmont Retina Specialist
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Hickory, North Carolina, Forenede Stater, 28602
- Graystone Eye
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Wake Forest, North Carolina, Forenede Stater, 27587
- North Carolina Retina Associates
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Western Carolina Clinical Research, LLC
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Retina Northwest
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Springfield, Oregon, Forenede Stater, 97477
- Cascade Medical Research Institute
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16507
- Erie Retina Research
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- Vision Research Solutions PLLC
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South Carolina
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Aiken, South Carolina, Forenede Stater, 29802
- Palmetto Retina Center
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Beaufort, South Carolina, Forenede Stater, 29902
- Charleston Neuroscience Institute, LLC
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Charleston, South Carolina, Forenede Stater, 29414
- Charleston Neuroscience Institute, LLC
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Ladson, South Carolina, Forenede Stater, 29456
- Charleston Neuroscience Institute, LLC
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Mt. Pleasant, South Carolina, Forenede Stater, 29464
- Charleston Neuroscience Institute
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West Columbia, South Carolina, Forenede Stater, 29169
- Palmetto Retina Center
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Ophthalmology Ltd
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Charles Retina Institute
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Texas
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Abilene, Texas, Forenede Stater, 79606
- Retina Research Institute of Texas
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Amarillo, Texas, Forenede Stater, 79106
- Panhandle Eye Group, LLP. - Southwest Retina Specialists
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Arlington, Texas, Forenede Stater, 76012
- Texas Retina Associates
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Austin, Texas, Forenede Stater, 78705
- Austin Research Center for Retina
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Austin, Texas, Forenede Stater, 78705
- Austin Retina Associates, PLLC
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Bellaire, Texas, Forenede Stater, 77401
- Retina Consultants of Texas
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Burleson, Texas, Forenede Stater, 76028
- Star Vision Research
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Fort Worth, Texas, Forenede Stater, 76104
- Texas Retina Associates
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Houston, Texas, Forenede Stater, 77030
- Texas Retina Center
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Katy, Texas, Forenede Stater, 77494
- Retina Consultants of Texas
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Plano, Texas, Forenede Stater, 75075
- Texas Retina Associates
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Round Rock, Texas, Forenede Stater, 78681
- Austin Retina Associates, PLLC
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San Antonio, Texas, Forenede Stater, 78240
- Retinal Consultants of Houston dba Retina Consultants of Texas
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Schertz, Texas, Forenede Stater, 78154
- Retina Consultants of Texas
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The Woodlands, Texas, Forenede Stater, 77384
- Retina Consultants of Texas
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Willow Park, Texas, Forenede Stater, 76087
- Strategic Clinical Research Group, LLC
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24502
- Piedmont Eye Center
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Washington
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Bellevue, Washington, Forenede Stater, 98004
- Pacific Northwest Retina
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Spokane, Washington, Forenede Stater, 99204
- Spokane Eye Clinical Research
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Wisconsin
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Wausau, Wisconsin, Forenede Stater, 54403
- Eye Clinic of Wisconsin
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Puerto Rico
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Arecibo, Puerto Rico, Puerto Rico, 00612
- Emanuelli Research & Development Center, LLC
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Intravitreal injection
Andre navne:
|
|
Eksperimentel: 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) |
Intravitreal injection
Andre navne:
|
|
Aktiv komparator: Aflibercept 2 mg
Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing |
Intravitreal injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Best corrected visual acuity (BCVA)
Tidsramme: Week 48
|
Mean change in BCVA from Day 1 to Year 1 |
Week 48
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Pablo Velazquez-Martin, MD, Kodiak Sciences Inc
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. august 2024
Primær færdiggørelse (Faktiske)
2. september 2026
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
12. august 2024
Først indsendt, der opfyldte QC-kriterier
13. august 2024
Først opslået (Faktiske)
16. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KS301P109
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .