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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

NCT ID: NCT04597632

Last Updated: 2024-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2023-03-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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brolucizumab 6 mg

Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity.

Group Type EXPERIMENTAL

brolucizumab

Intervention Type DRUG

brolucizumab 6 mg/0.05 mL solution for intravitreal injection

Interventions

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brolucizumab

brolucizumab 6 mg/0.05 mL solution for intravitreal injection

Intervention Type DRUG

Other Intervention Names

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RTH258

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
2. Discontinued study treatment in the core study
3. Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.
4. Pregnant or nursing (lactating) women
5. Women of child-bearing potential not using highly effective methods of contraception
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Huntington Beach, California, United States

Site Status

Novartis Investigative Site

Fort Lauderdale, Florida, United States

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Novartis Investigative Site

Indianapolis, Indiana, United States

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Minneapolis, Minnesota, United States

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Germantown, Tennessee, United States

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Albury, New South Wales, Australia

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Hurstville, New South Wales, Australia

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Parramatta, New South Wales, Australia

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Sydney, New South Wales, Australia

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Glen Waverley, Victoria, Australia

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Rowville, Victoria, Australia

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Nedlands, Western Australia, Australia

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Hasselt, , Belgium

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Hradec Králové, CZE, Czechia

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Prague, , Czechia

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Prague, , Czechia

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Saint-Cyr-sur-Loire, Indre Et Loire, France

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Lyon, Rhone, France

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Bordeaux, , France

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Créteil, , France

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Marseille, , France

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Montauban, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Rueil-Malmaison, , France

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Freiburg im Breisgau, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Jerusalem, , Israel

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Ramat Gan, , Israel

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Ẕerifin, , Israel

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Perugia, PG, Italy

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Malacca, Melaka Malaysia, Malaysia

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Batu Caves, Selangor, Malaysia

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Shah Alam, Selangor, Malaysia

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's-Hertogenbosch, , Netherlands

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Nijmegen, , Netherlands

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Porto, , Portugal

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Vila Franca de Xira, , Portugal

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Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

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Seoul, Seocho Gu, South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, Catalonia, Spain

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Sant Cugat del Vallès, Catalonia, Spain

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Pamplona, Navarre, Spain

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Burjassot, Valencia, Spain

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Novartis Investigative Site

Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Zaragoza, , Spain

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Novartis Investigative Site

Örebro, , Sweden

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Novartis Investigative Site

Västerås, , Sweden

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Novartis Investigative Site

Binningen, , Switzerland

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Novartis Investigative Site

Taipei, , Taiwan

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Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Taoyuan District, , Taiwan

Site Status

Countries

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United States Australia Belgium Czechia France Germany Israel Italy Malaysia Netherlands Portugal South Korea Spain Sweden Switzerland Taiwan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1913

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

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2020-002349-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRTH258A2303E1

Identifier Type: -

Identifier Source: org_study_id

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