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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597632 on ClinicalTrials.gov