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

Completed · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04597632

Run by

Novartis Pharmaceuticals

People needed

248

Starts

2020-12-16

Expected to finish

2023-03-28

Last updated by the study team

2024-10-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Successfully completed TALON core study at week 64 (End of Study)

You may not qualify if…

• Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
• Discontinued study treatment in the core study
• Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential not using highly effective methods of contraception

Where it is running

• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Germantown, Tennessee, United States
• Novartis Investigative Site — Albury, New South Wales, Australia
• Novartis Investigative Site — Hurstville, New South Wales, Australia
• Novartis Investigative Site — Parramatta, New South Wales, Australia
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Glen Waverley, Victoria, Australia
• Novartis Investigative Site — Rowville, Victoria, Australia
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Hasselt, Belgium
• Novartis Investigative Site — Hradec Králové, CZE, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Saint-Cyr-sur-Loire, Indre Et Loire, France
• Novartis Investigative Site — Lyon, Rhone, France
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Montauban, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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