Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06556368 | 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 | PHASE3 | ACTIVE NOT_RECRUITING | 675 | — | — | Aug 23, 2024 | Aug 1, 2027 | Apr 29, 2026 | 72 | United States, Puerto Rico |
Mean change in BCVA from Day 1 to Year 1
| Arm | Type | Description |
|---|---|---|
| Tarcocimab tedromer 5 mg (KSI-301) | EXPERIMENTAL | 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) | EXPERIMENTAL | 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 | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing |
| Name | Type | Description |
|---|---|---|
| Tarcocimab tedromer | DRUG | Intravitreal injection |
| Tabirafusp tedromer | DRUG | Intravitreal injection |
| Aflibercept | DRUG | Intravitreal injection |
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 ...