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Monoclonal Antibodies

Tarcocimab + Tabirafusp for Wet Age-Related Macular Degeneration (DAYBREAK Trial)

Phase 3
Recruiting
Research Sponsored by Kodiak Sciences Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Summary

"This trial aims to see if two new drugs, Tarcocimab Tedromer and Tabirafusp Tedromer, are as effective and safe as Aflibercept in treating wet

Who is the study for?
This trial is for individuals with wet age-related macular degeneration (wAMD). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of wAMD and meet certain health standards.
What is being tested?
The study tests the effectiveness and safety of two drugs, Tarcocimab Tedromer and Tabirafusp Tedromer, against Aflibercept in treating wAMD. It's likely that patients will be randomly assigned to receive one of these treatments.
What are the potential side effects?
While specific side effects aren't listed here, treatments for wAMD like those being tested can sometimes cause eye irritation or discomfort, blurred vision, or an increased risk of eye infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a specific type of untreated eye condition related to AMD that affects my vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My vision in my non-study eye is very poor or I only have one eye.
Select...
Over half of the lesion in my eye is scarred or has thinned, affecting the central vision area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best corrected visual acuity (PCVA

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tarcocimab tedromer 5 mg (KSI-301)Experimental Treatment1 Intervention
Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
Group II: Tabirafusp tedromer 5 mg (KSI-501)Experimental Treatment1 Intervention
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
Group III: Aflibercept 2 mgActive Control1 Intervention
Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Find a Location

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor
8 Previous Clinical Trials
3,227 Total Patients Enrolled
Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc
8 Previous Clinical Trials
3,227 Total Patients Enrolled
~450 spots leftby Jan 2026
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