CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
brolucizumabdrug
Likely dose
brolucizumab 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04597632
NCT04597632Phase 3Completed

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

Novartis Pharmaceuticals·interventional·Posted Oct 22, 2020·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating brolucizumab for Neovascular Age-related Macular Degeneration. Completed, enrolled 248 participants across 60 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Czechia, France, Germany, Israel, Italy, Malaysia, Netherlands, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 22, 2020
Enrollment StartDec 16, 2020
Primary CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.7 years ago

Interventions

brolucizumabdrug

brolucizumab 6 mg/0.05 mL solution for intravitreal injection