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brolucuzumab IVT · 1 trial · 6 indications
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 ...
Brolucuzumab IVT is an investigational monoclonal antibody being studied for the treatment of Age-Related Macular Degeneration (AMD), specifically wet AMD. It is administered via intravitreal injection. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Brolucuzumab IVT is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for Age-Related Macular Degeneration.
Brolucuzumab IVT is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing clinical program is evaluating its use in patients with Age-Related Macular Degeneration, specifically wet AMD, through intravitreal administration.
Brolucuzumab IVT has one completed Phase 3 clinical trial registered under NCT03954626. This study, titled 'Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD,' enrolled 14 participants aged 50 years and older in the United States and Puerto Rico.
Yes, brolucuzumab IVT is the same drug as brolucizumab, with 'IVT' indicating the intravitreal route of administration. The clinical trial NCT03954626 refers to the drug as brolucizumab 6 mg intravitreal treatment, confirming that brolucuzumab IVT and brolucizumab are the same investigational monoclonal antibody.