Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Kodiak Sciences Inc
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT06556368
Start Date
August 23 2024
End Date
August 1 2027
Last Update
October 27 2025
Active Locations (72)
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1
Associated Retina Consultants
Gilbert, Arizona, United States, 85297
2
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
3
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States, 85255
4
Retina Associates SW
Tucson, Arizona, United States, 85704