Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

NCT ID: NCT04005352

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 734 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2022-09-09

Brief Summary

This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.

Detailed Description

At the baseline Visit, subjects who met the eligibility criteria were randomized in a 1:1 ratio to receive either: -Brolucizumab 6 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

-Aflibercept 2 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to-Control treatment from Week 16 up to Week 60/62.

For all subjects, the last potential study treatment was at the Week 60 visit (or at the Week 62 visit for subjects whose actual treatment interval would require a treatment at Week 62). The initiation phase starts on Day 1 and ends on Week 16. Treat to Control regimen starts on Week 16 until end of treatment (Week 60/62).

In both treatment arms, treatment intervals after the initiation phase were either 8 weeks, 12 weeks, or 16 weeks. Per the original protocol, if it was determined that a patient required more frequent injections than q8w, he/she would be moved to a q4w treatment interval. However, this option was removed per Protocol amendment 02, after which, dosing intervals shorter than q8w were not permitted.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Brolucizumab 6 mg

3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.

Group Type: EXPERIMENTAL

Brolucizumab 6 mg

Intervention Type: BIOLOGICAL

Intra-vitreal injection

Aflibercept 2 mg

3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

Group Type: ACTIVE_COMPARATOR

Aflibercept 2 mg

Intervention Type: BIOLOGICAL

Intra-vitreal injection

Interventions

Brolucizumab 6 mg

Intra-vitreal injection

Intervention Type: BIOLOGICAL

Aflibercept 2 mg

Intra-vitreal injection

Intervention Type: BIOLOGICAL

Other Intervention Names

RTH258; EYLEA

Eligibility Criteria

Inclusion Criteria

• Signed informed consent must be obtained prior to participation in the study
• Male or female patients ≥ 50 years of age at screening who are treatment naive
• Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (study eye)
• Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye)
• Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)

Exclusion Criteria

• Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
• Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
• Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
• Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular surgery (study eye)
• Stroke or myocardial infarction during the 6-month period prior to baseline
• Systemic anti-VEGF therapy at any time.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

Huntington Beach, California, United States

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Loma Linda, California, United States

Novartis Investigative Site

Riverside, California, United States

Novartis Investigative Site

Santa Ana, California, United States

Novartis Investigative Site

Fort Lauderdale, Florida, United States

Novartis Investigative Site

Fort Myers, Florida, United States

Novartis Investigative Site

Orlando, Florida, United States

Novartis Investigative Site

Pinellas Park, Florida, United States

Novartis Investigative Site

Winter Haven, Florida, United States

Novartis Investigative Site

Springfield, Illinois, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

West Des Moines, Iowa, United States

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Minneapolis, Minnesota, United States

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Hickory, North Carolina, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, De Santa Fe, Argentina

Novartis Investigative Site

Caba, , Argentina

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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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Southport, Queensland, 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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Vienna, , Austria

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Vienna, , Austria

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Alken, , Belgium

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Leuven, , Belgium

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Brampton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Boisbriand, Quebec, Canada

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Québec, Quebec, Canada

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Zlín, Czech Republic, Czechia

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Hradec Králové, CZE, Czechia

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Ostrava Poruba, , 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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Strasbourg, , France

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Berlin, , Germany

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Bonn, , Germany

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Düsseldorf, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Kempten, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Münster, , Germany

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Münster, , Germany

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Ulm, , Germany

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Jerusalem, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Ẕerifin, , Israel

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Bologna, BO, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Palermo, PA, Italy

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Perugia, PG, Italy

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Novara, , 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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Coimbra, , Portugal

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Porto, , Portugal

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Vila Franca de Xira, , Portugal

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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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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Zaragoza, , Spain

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Örebro, , Sweden

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Västerås, , Sweden

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Binningen, , Switzerland

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bradford, West Yorkshire, United Kingdom

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London, , United Kingdom

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Rugby, , United Kingdom

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Sunderland, , United Kingdom

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Torquay, , United Kingdom

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Wolverhampton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; Czechia; France; Germany; Israel; Italy; Malaysia; Netherlands; Portugal; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1914

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

Other Identifiers

2019-000716-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRTH258A2303

Identifier Type: -

Identifier Source: org_study_id