NCT04679935

Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of two different brolucizumab 6 mg dosing regimens in patients with visual impairment due to age-related macular degeneration (AMD) who have previously received anti-VEGF (vascular endothelial growth factor) treatment.

Detailed description

This study was a 52-week randomized, open-label, multi-center, two-arm study for pretreated patients with suboptimal anatomically controlled nAMD. Patients who consented were screened to evaluate eligibility. Eligible patients were randomized in a 1:1 ratio to one of the two treatment arms: * Brolucizumab 6 mg "loading arm": 1 loading injection every 4 weeks for 3 consecutive injections (baseline, weeks 4 and 8) followed by an injection every 12 weeks. * Brolucizumab 6 mg "non-loading arm": one initial injection followed by an injection every 12 weeks There were three periods in this study: * Screening period: from day -14 to baseline * Open-label treatment period: from baseline (day 1) to week 48 * Post-treatment follow-up period: from week 48 to week 52 In both study arms, treatment intervals after the initiation phase were either 8 weeks or 12 weeks depending on disease activity status. More frequent injections, i.e., treatment intervals of \< 8 weeks were not allowed after the initiation phase.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	Brolucizumab	Intravitreal injection

Timeline

• Start date: 2021-07-13
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2020-12-22
• Last updated: 2025-09-26
• Results posted: 2025-01-27

Locations

19 sites across 2 countries: Germany, Switzerland