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
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of this extension study is 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 is to assess brolucizumab's potential for long durability up to 20 weeks.
All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.
The study period is 56 weeks including post-treatment follow-up.
Neovascular Age-related Macular Degeneration
Dec 16, 2020
Mar 31, 2023
50 Years and older (Adult, Older Adult)
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Signed informed consent
Successfully completed TALON core study at week 64 (End of Study)
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