NCT04597632

An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks. All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study. The study period was 56 weeks including post-treatment follow-up.

Detailed description

This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study. The maximum study duration for a subject was 56 weeks, including post-treatment follow-up. There were two periods in this study: * Treat-to-Control treatment period: from Baseline (Day 1) to Week 52 * Post-treatment follow-up period: from Week 52 to Week 56. All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept). Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	brolucizumab	brolucizumab 6 mg/0.05 mL solution for intravitreal injection

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2020-10-22
• Last updated: 2024-10-09
• Results posted: 2024-04-04

Locations

60 sites across 16 countries: United States, Australia, Belgium, Czechia, France, Germany, Israel, Italy, Malaysia, Netherlands, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study