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

Phase 3

Recruiting

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Tarcocimab tedromer; Drug: Tabirafusp tedromer; Drug: Aflibercept

• Registration Number: NCT06556368
• Lead Sponsor: Kodiak Sciences Inc

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Study Start: 2024-08-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 675

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tarcocimab tedromer 5 mg (KSI-301)	Tarcocimab tedromer	Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
Tabirafusp tedromer 5 mg (KSI-501)	Tabirafusp tedromer	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)
Aflibercept 2 mg	Aflibercept	Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (PCVA	Week 48	Mean change in BCVA from Day 1 to Year 1

Trial Locations

Locations (62)

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Retina Associates SW; 🇺🇸 Tucson, Arizona, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Global Research Management, Inc. - Lugene Eye Institute; 🇺🇸 Glendale, California, United States

Retinal Consultants Medical Group, Inc.; 🇺🇸 Modesto, California, United States

California Retina Consultants; 🇺🇸 Oxnard, California, United States

California Eye Specialists Medical Group, Inc.; 🇺🇸 Redlands, California, United States

Retinal Consultants Medical Group Inc; 🇺🇸 Sacramento, California, United States

Retina Consultants of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

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