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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

Pivotal Trial

No Placebo-Only Group

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

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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:

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met