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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 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)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06556368
Acronym
DAYBREAK
Enrollment
675
Registered
2024-08-16
Start date
2024-08-23
Completion date
2027-08-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration

Keywords

Wet AMD, KSI-301, KSI-501, Tarcocimab, Tabirafusp, Aflibercept, Antibody biopolymer conjugate, AMD, Anti-VEGF, Vascular endothelial growth factor, Kodiak Sciences

Brief 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)

Interventions

DRUGTarcocimab tedromer

Intravitreal injection

DRUGTabirafusp tedromer

Intravitreal injection

DRUGAflibercept

Intravitreal injection

Sponsors

Kodiak Sciences Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants will be randomized 1:1:1 into one of three treatment groups: tarcocimab-ted, tabirafusp-ted or aflibercept.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuity (BCVA)Week 48Mean change in BCVA from Day 1 to Year 1

Countries

Puerto Rico, United States

Contacts

STUDY_DIRECTORPablo Velazquez-Martin, MD

Kodiak Sciences Inc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026