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: Jun 14, 2022

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

Apr 20, 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