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

Running, not enrolling · Phase 3

Conditions studied: Wet Age-related Macular Degeneration

In brief

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 facts

Study ID

NCT06556368

Run by

Kodiak Sciences Inc

People needed

675

Starts

2024-08-23

Expected to finish

2027-08-01

Last updated by the study team

2026-04-29

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 Eye Specialists Medical Group, Inc. — Pasadena, 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
• Retina Group of Florida — Fort Lauderdale, 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
• Retina Associates, Ltd — Elmhurst, Illinois, 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
• The Retina Care Center — Baltimore, Maryland, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Associated Retina Consultants — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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