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

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Brolucizumab 6 mg

Aflibercept 2 mg

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Age-related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, AMD, nAMD, wet AMD, RTH258, Brolucizumab, double blind, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brolucizumab

Aflibercept

Arm Description

Intra-vitreal injection

Outcomes

Primary Outcome Measures

Average change in Best-corrected visual acuity

Visual acuity test

Distribution of the last interval with no disease activity

Treatment interval distribution

Secondary Outcome Measures

Distribution of the last interval with no disease activity

Treatment interval distribution

Distribution of the maximal intervals with no disease activity

Treatment interval distribution

Proportion of patients with no disease activit

Disease activity assessment

Time from the last loading injection to the first visit with no disease activity

Disease activity assessment

Average change in Best-corrected visual acuity

Visual acuity test

Occurrence of Best-corrected visual acuity improvements of ≥ 10 and ≥ 15 letters

Visual acuity test

Occurrence of Best-corrected visual acuity ≥ 69 letters

Visual acuity test

Average change from baseline in Central Subfield Thickness

Spectral Domain Optical Coherence Tomography

Average change from baseline in Central Subfield Thickness

Spectral Domain Optical Coherence Tomography

Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield

Spectral Domain Optical Coherence Tomography

Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield

Spectral Domain Optical Coherence Tomography

Change in Visual Function Questionnnaire-25

Visual Function Questionnnaire-25

Full Information

NCT ID

NCT04005352

First Posted

July 1, 2019

Last Updated

May 30, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04005352

Brief Title

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

Acronym

TALON

Official Title

A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 25, 2019 (Actual)

Primary Completion Date

September 9, 2022 (Actual)

Study Completion Date

September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

The 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. 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. At the investigator's discretion, an inspection visit 6 weeks after the last injection could be performed when the injection interval was extended from 4 weeks to 8 weeks, i.e., after the 3rd injection at Week 8. If there was no disease activity in the study eye at the inspection visit, as assessed by the masked investigator, no treatment should be administered and the next visit and injection should take place 2 weeks later, i.e., 8 weeks after the previous study treatment. If disease activity was observed by the masked investigator in the study eye at the inspection visit at Week 14, the study treatment should be administered by the unmasked investigator, and the subject should be discontinued from further study treatment at the next visit. Inspection visits 10 weeks and 14 weeks after the last injection could have been performed when the injection interval was extended from 8 weeks to 12 weeks, and from 12 weeks to 16 weeks, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

Age-related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, AMD, nAMD, wet AMD, RTH258, Brolucizumab, double blind, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Double arm, multi-center

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

737 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brolucizumab

Arm Type

Experimental

Arm Description

Intra-vitreal injection

Arm Title

Aflibercept

Arm Type

Active Comparator

Arm Description

Intra-vitreal injection

Intervention Type

Biological

Intervention Name(s)

Brolucizumab 6 mg

Other Intervention Name(s)

RTH258

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Aflibercept 2 mg

Other Intervention Name(s)

EYLEA

Intervention Description

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

Primary Outcome Measure Information:

Title

Average change in Best-corrected visual acuity

Description

Visual acuity test

Time Frame

At Weeks 28 and 32

Title

Distribution of the last interval with no disease activity

Description

Treatment interval distribution

Time Frame

Up to Week 32

Secondary Outcome Measure Information:

Title

Distribution of the last interval with no disease activity

Description

Treatment interval distribution

Time Frame

Up to Week 64

Title

Distribution of the maximal intervals with no disease activity

Description

Treatment interval distribution

Time Frame

Up to Week 64

Title

Proportion of patients with no disease activit

Description

Disease activity assessment

Time Frame

At Weeks 14 and 16

Title

Time from the last loading injection to the first visit with no disease activity

Description

Disease activity assessment

Time Frame

Week 8 to week 62

Title

Average change in Best-corrected visual acuity

Description

Visual acuity test

Time Frame

At Weeks 60 and 64

Title

Occurrence of Best-corrected visual acuity improvements of ≥ 10 and ≥ 15 letters

Description

Visual acuity test

Time Frame

At Week 32, Week 64, and at the last injection visit

Title

Occurrence of Best-corrected visual acuity ≥ 69 letters

Description

Visual acuity test

Time Frame

At Week 32, at Week 64, and at the last injection visit

Title

Average change from baseline in Central Subfield Thickness

Description

Spectral Domain Optical Coherence Tomography

Time Frame

At Weeks 28 and 32

Title

Average change from baseline in Central Subfield Thickness

Description

Spectral Domain Optical Coherence Tomography

Time Frame

At Weeks 60 and 64

Title

Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield

Description

Spectral Domain Optical Coherence Tomography

Time Frame

At Weeks 28 and 32

Title

Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield

Description

Spectral Domain Optical Coherence Tomography

Time Frame

At Weeks 60 and 64

Title

Change in Visual Function Questionnnaire-25

Description

Visual Function Questionnnaire-25

Time Frame

At Weeks 32 and 64

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Novartis Investigative Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Novartis Investigative Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Novartis Investigative Site

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912-7125

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46280

Country

United States

Facility Name

Novartis Investigative Site

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Novartis Investigative Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Novartis Investigative Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Novartis Investigative Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Novartis Investigative Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1116

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

De Santa Fe

ZIP/Postal Code

B7602

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

C1056

Country

Argentina

Facility Name

Novartis Investigative Site

City

Albury

State/Province

New South Wales

ZIP/Postal Code

2640

Country

Australia

Facility Name

Novartis Investigative Site

City

Hurstville

State/Province

New South Wales

ZIP/Postal Code

2220

Country

Australia

Facility Name

Novartis Investigative Site

City

Parramatta

State/Province

New South Wales

ZIP/Postal Code

2150

Country

Australia

Facility Name

Novartis Investigative Site

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

Facility Name

Novartis Investigative Site

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Novartis Investigative Site

City

Glen Waverley

State/Province

Victoria

ZIP/Postal Code

3150

Country

Australia

Facility Name

Novartis Investigative Site

City

Rowville

State/Province

Victoria

ZIP/Postal Code

3179

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Novartis Investigative Site

City

Alken

ZIP/Postal Code

3570

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6Y 0P6

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Boisbriand

State/Province

Quebec

ZIP/Postal Code

J7H 1S6

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Novartis Investigative Site

City

Zlin

State/Province

Czech Republic

ZIP/Postal Code

762 75

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Saint Cyr sur Loire

State/Province

Indre Et Loire

ZIP/Postal Code

37540

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Novartis Investigative Site

City

Creteil

ZIP/Postal Code

94000

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

F 13008

Country

France

Facility Name

Novartis Investigative Site

City

Montauban

ZIP/Postal Code

82000

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 10

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Rueil Malmaison

ZIP/Postal Code

92500

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Kempten

ZIP/Postal Code

87435

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Zerifin

ZIP/Postal Code

6093000

Country

Israel

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06100

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Daegu

ZIP/Postal Code

705703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

07301

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Melaka

State/Province

Melaka Malaysia

ZIP/Postal Code

75000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Shah Alam

State/Province

Selangor

ZIP/Postal Code

40000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Hertogenbosch

ZIP/Postal Code

5200

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 EX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000 075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Franca de Xira

ZIP/Postal Code

2600-009

Country

Portugal

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08022

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Cugat

State/Province

Catalunya

ZIP/Postal Code

08190

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Burjassot

State/Province

Valencia

ZIP/Postal Code

46100

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08024

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

14012

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Oerebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Vasteras

ZIP/Postal Code

72189

Country

Sweden

Facility Name

Novartis Investigative Site

City

Binningen

ZIP/Postal Code

4102

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

103616

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Rugby

ZIP/Postal Code

CV22 5PX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sunderland

ZIP/Postal Code

SR2 9HP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Torquay

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

IPD Sharing URL

https://clinicalstudydatarequest.com/

Learn more about this trial

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

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

Age-related Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial