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
NCT04597632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2024-10-09
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.
Conditions
- Neovascular Age-related Macular Degeneration
Interventions
- DRUG
-
brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-16
- Primary Completion
- 2023-03-28
- Completion
- 2023-03-28
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Czechia
- France
- Germany
- Israel
- Italy
- Malaysia
- Netherlands
- Portugal
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
Study Locations
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