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

Kodiak Sciences

Status and phase: Enrolling; Phase 3

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: Tarcocimab tedromer; Drug: Aflibercept; Drug: Tabirafusp tedromer

Study type: Interventional

Funder types: Industry

Identifiers

NCT06556368

KS301P109

Details and patient eligibility

About

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)

Enrollment: 675 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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675 participants in 3 patient groups

Tarcocimab tedromer 5 mg (KSI-301)

Experimental group

Description:

Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.

Treatment:

Drug: Tarcocimab tedromer

Tabirafusp tedromer 5 mg (KSI-501)

Experimental group

Description:

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)

Treatment:

Drug: Tabirafusp tedromer

Aflibercept 2 mg

Active Comparator group

Description:

Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Treatment:

Drug: Aflibercept