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

Description

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)

Conditions

Wet Age-related Macular Degeneration

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Study Overview

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Study Details

Study overview

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)

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (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) - DAYBREAK

Condition
Wet Age-related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Glendale

Global Research Management, Inc. - Lugene Eye Institute, Glendale, California, United States, 91204

Modesto

Retinal Consultants Medical Group, Inc., Modesto, California, United States, 95356

Oxnard

California Retina Consultants, Oxnard, California, United States, 93036

Sacramento

Retinal Consultants Medical Group Inc, Sacramento, California, United States, 95825

Colorado Springs

Retina Consultants of Southern Colorado, Colorado Springs, Colorado, United States, 80909

Waterford

Retina Group of New England, PC, Waterford, Connecticut, United States, 06385

Fort Myers

National Ophthalmic Research Institute, Fort Myers, Florida, United States, 33912

Winter Haven

Center for Retina and Macular Disease, Winter Haven, Florida, United States, 33880

Augusta

Southeast Retina Center, Augusta, Georgia, United States, 30909

Carmel

Associated Vitreoretinal and Uveitis Consultants LLC, Carmel, Indiana, United States, 46032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kodiak Sciences Inc,

Pablo Velazquez-Martin, MD, STUDY_DIRECTOR, Kodiak Sciences Inc

Study Record Dates

2026-01