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NCT Number: NCT06556368

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emanuelli Research & Development Center, LLC, Arecibo, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tarcocimab tedromer

Drug

Intravitreal injection

Other names: KSI-301

Tabirafusp tedromer

Drug

Intravitreal injection

Other names: KSI-501

aflibercept

Drug

Intravitreal injection

Other names: Eylea

Primary outcomes

  1. Best corrected visual acuity (BCVA)

    Time frame: Week 48

    Mean change in BCVA from Day 1 to Year 1

Sponsors and collaborators

Lead sponsor

Kodiak Sciences Inc

Industry

Registry information

Official study title

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)

Acronym: DAYBREAK

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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