NCT03954626

Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD

A Single-Arm, Open-Label, Multicenter, Phase IIIb Study to Collect Safety and Electrocardiogram Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to collect ECG data after a single IVT injection of brolucizumab 6 mg in patients with neovascular age-related macular degeneration (nAMD).

Detailed description

This is a single-arm, open-label, multicenter study that collected ECG data after a single IVT injection of brolucizumab 6 mg in patients with nAMD. Triplicate 12-lead ECG recording was performed at screening to determine eligibility. A second triplicate 12-lead ECG recording was collected approximately 2h prior to the brolucizumab IVT injection on Day 1. Holter ECG recording started approximately 1 h prior to the brolucizumab IVT injection and ended approximately 48h after the IVT injection. A third triplicate 12-lead ECG recording was performed after the conclusion of Holter monitoring on Day 3.

Conditions

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration
• Retinal Degeneration
• Retinal Diseases
• Eye Diseases

Interventions

Type	Name	Description
BIOLOGICAL	brolucuzumab 6 mg IVT	Single intravitreal injection (IVT) of brolucizumab 6 mg

Timeline

• Start date: 2019-06-07
• Primary completion: 2019-07-09
• Completion: 2019-07-31
• First posted: 2019-05-17
• Last updated: 2021-01-05
• Results posted: 2020-08-13

Locations

3 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study