Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-31 @ 12:05 PM
Study NCT ID:
NCT04597632
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TALON Ext
Brief 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.
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.
Detailed Description:
This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
* Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
* Post-treatment follow-up period: from Week 52 to Week 56.
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
* Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
* Post-treatment follow-up period: from Week 52 to Week 56.
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
Treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals were to have been 4 weeks at a time if disease activity recurs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-002349-40 | EUDRACT_NUMBER | None | View |