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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Kodiak Sciences Inc
Study ID
NCT06556368
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarcocimab tedromer — DRUG
    Intravitreal injection
  • Tabirafusp tedromer — DRUG
    Intravitreal injection
  • Aflibercept — DRUG
    Intravitreal injection

Study Details

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)

Key Dates

Start date
Aug 23, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
675 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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)
  • Active Comparator: Aflibercept 2 mg
    Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Primary Outcome Measure

Best corrected visual acuity (BCVA) [ Time Frame: Week 48 ]

Locations (71)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsGilbertArizona85297-
Associated Retina ConsultantsPhoenixArizona85020-
Retina Macula Institute of ArizonaScottsdaleArizona85255-
Retina Associates SWTucsonArizona85704-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Global Research Management, Inc. - Lugene Eye InstituteGlendaleCalifornia91204-
Retinal Consultants Medical Group, Inc.ModestoCalifornia95356-
California Eye Specialists Medical Group, Inc.PasadenaCalifornia91107-
California Eye Specialists Medical Group, Inc.RedlandsCalifornia92373-
Retinal Consultants Medical Group IncSacramentoCalifornia95825-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Retina Group of New England, PCWaterfordConnecticut06385-
Blue Ocean Clinical ResearchClearwaterFlorida33761-
Retina Group of FloridaFort LauderdaleFlorida33308-
National Ophthalmic Research InstituteFort MyersFlorida33912-
Retina Group of FloridaSarasotaFlorida34232-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Southeast Retina CenterAugustaGeorgia30909-
Retina Associates, LtdElmhurstIllinois60126-
Illinois Retina AssociatesOak ParkIllinois60304-
Associated Vitreoretinal and Uveitis Consultants LLCCarmelIndiana46032-
Midwest Eye InstituteCarmelIndiana46290-
The Retina Care CenterBaltimoreMaryland21209-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of MinnesotaEdinaMinnesota55435-
Retina Consultants of MinnesotaSaint Louis ParkMinnesota55416-
Mississippi Retina AssociatesMadisonMississippi39110-
The Retina InstituteSt LouisMissouri63128-
Retina Consultants of NevadaHendersonNevada89052-
Long Island Vitreoretinal ConsultantsHauppaugeNew York11788-
Retina Vitreous Surgeons of CNY PCLiverpoolNew York13088-
Retina Associates of Western NYRochesterNew York14620-
Asheville Eye AssociatesAshevilleNorth Carolina28803-
North Carolina Retina AssociatesCaryNorth Carolina27511-
Piedmont Retina SpecialistGreensboroNorth Carolina27401-
Graystone EyeHickoryNorth Carolina28602-
North Carolina Retina AssociatesWake ForestNorth Carolina27587-
Western Carolina Clinical Research, LLCWinston-SalemNorth Carolina27103-
Retina NorthwestPortlandOregon97210-
Cascade Medical Research InstituteSpringfieldOregon97477-
Erie Retina ResearchEriePennsylvania16507-
Vision Research Solutions PLLCPhiladelphiaPennsylvania19141-
Palmetto Retina CenterAikenSouth Carolina29802-
Charleston Neuroscience Institute, LLCBeaufortSouth Carolina29902-
Charleston Neuroscience Institute, LLCCharlestonSouth Carolina29414-
Charleston Neuroscience Institute, LLCLadsonSouth Carolina29456-
Charleston Neuroscience InstituteMt. PleasantSouth Carolina29464-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Ophthalmology LtdSioux FallsSouth Dakota57108-
Charles Retina InstituteGermantownTennessee38138-
Retina Research Institute of TexasAbileneTexas79606-
Panhandle Eye Group, LLP. - Southwest Retina SpecialistsAmarilloTexas79106-
Texas Retina AssociatesArlingtonTexas76012-
Austin Research Center for RetinaAustinTexas78705-
Austin Retina Associates, PLLCAustinTexas78705-
Retina Consultants of TexasBellaireTexas77401-
Star Vision ResearchBurlesonTexas76028-
Texas Retina AssociatesFort WorthTexas76104-
Texas Retina CenterHoustonTexas77030-
Retina Consultants of TexasKatyTexas77494-
Texas Retina AssociatesPlanoTexas75075-
Austin Retina Associates, PLLCRound RockTexas78681-
Retinal Consultants of Houston dba Retina Consultants of TexasSan AntonioTexas78240-
Retina Consultants of TexasSchertzTexas78154-
Retina Consultants of TexasThe WoodlandsTexas77384-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-
Piedmont Eye CenterLynchburgVirginia24502-
Pacific Northwest RetinaBellevueWashington98004-
Spokane Eye Clinical ResearchSpokaneWashington99204-
Eye Clinic of WisconsinWausauWisconsin54403-

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