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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03954626 | Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD | PHASE3 | COMPLETED | 14 | — | — | Jun 7, 2019 | Jul 31, 2019 | Jan 5, 2021 | 3 | United States, Puerto Rico |
Incidence between 20 and 24 h post-injection of clinically relevant treatment emergent changes in heart rate (HR), pulse rate (PR), QRS, and QTc (heart rate corrected QT using Fridericia's formula, QTcF) interval (ms). This is a composite endpoint capturing all 4 parameters and 3 time-points in one Outcome Measure.
| Arm | Type | Description |
|---|---|---|
| RTH258 | EXPERIMENTAL | Intravitreal injection |
| Name | Type | Description |
|---|---|---|
| brolucuzumab 6 mg IVT | BIOLOGICAL | Single intravitreal injection (IVT) of brolucizumab 6 mg |
Inclusion Criteria: * Signed informed consent MUST be obtained prior to participation in the study * Study eye is diagnosed with nAMD and deemed to be eligible for intravitreal injection at the discretion of the Investigator Exclusion Criteria: * Concomitant conditions or ocular disorders in the ...