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Clinical Trials in the USA / NCT06556368
Active, not recruiting Phase 3

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

NCT06556368 · tracked via the Priya Life Science USA tracker
Sponsor
Kodiak Sciences Inc
Phase
Phase 3
Started
2024-08-23
Last updated
2026-04-29

Condition(s) studied

Wet Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

Tarcocimab tedromerTabirafusp tedromer →Aflibercept →

Tarcocimab tedromer: Intravitreal injection

Tabirafusp tedromer: Intravitreal injection

Aflibercept: Intravitreal injection

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
Associated Retina Consultants Gilbert Arizona
Associated Retina Consultants Phoenix Arizona
Retina Macula Institute of Arizona Scottsdale Arizona
Retina Associates SW Tucson Arizona
Retina Consultants of Orange County Fullerton California
Global Research Management, Inc. - Lugene Eye Institute Glendale California
Retinal Consultants Medical Group, Inc. Modesto California
California Eye Specialists Medical Group, Inc. Pasadena California
California Eye Specialists Medical Group, Inc. Redlands California
Retinal Consultants Medical Group Inc Sacramento California
Retina Consultants of Southern Colorado Colorado Springs Colorado
Retina Group of New England, PC Waterford Connecticut
Blue Ocean Clinical Research Clearwater Florida
Retina Group of Florida Fort Lauderdale Florida
National Ophthalmic Research Institute Fort Myers Florida
Retina Group of Florida Sarasota Florida
Center for Retina and Macular Disease Winter Haven Florida
Southeast Retina Center Augusta Georgia
Retina Associates, Ltd Elmhurst Illinois
Illinois Retina Associates Oak Park Illinois
Associated Vitreoretinal and Uveitis Consultants LLC Carmel Indiana
Midwest Eye Institute Carmel Indiana
The Retina Care Center Baltimore Maryland
Cumberland Valley Retina Consultants Hagerstown Maryland
Ophthalmic Consultants of Boston Boston Massachusetts
Retina Consultants of Minnesota Edina Minnesota
Retina Consultants of Minnesota Saint Louis Park Minnesota
Mississippi Retina Associates Madison Mississippi
The Retina Institute St Louis Missouri
Retina Consultants of Nevada Henderson Nevada
Long Island Vitreoretinal Consultants Hauppauge New York
Retina Vitreous Surgeons of CNY PC Liverpool New York
Retina Associates of Western NY Rochester New York
Asheville Eye Associates Asheville North Carolina
North Carolina Retina Associates Cary North Carolina
Piedmont Retina Specialist Greensboro North Carolina
Graystone Eye Hickory North Carolina
North Carolina Retina Associates Wake Forest North Carolina
Western Carolina Clinical Research, LLC Winston-Salem North Carolina
Retina Northwest Portland Oregon

+ 32 more sites — see the full list on the official registry below.

More Kodiak Sciences Inc trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06556368 on ClinicalTrials.gov ↗ ← All trials in the USA