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

ClinicalTrials.gov Identifier: NCT04597632

Novartis Reference Number: CRTH258A2303E1

Last Update: Sep 16, 2022

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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. 

Study Description

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.

Condition 
Neovascular Age-related Macular Degeneration
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Dec 16, 2020
Completion date 
Mar 31, 2023
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

Drug
brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33309
Florida
United States
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08022
Cataluna
Spain
Novartis Investigative Site
Recruiting
Burjassot, 46100
Valencia
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
[email protected]
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-888-669-6682 or email [email protected]