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

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)

ClinicalTrials.gov Identifier: NCT04005352

Novartis Reference Number: CRTH258A2303

Last Update: Apr 15, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

Condition 
Age-related Macular Degeneration
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
692 participants
Start date 
Sep 25, 2019
Completion date 
Jan 06, 2023
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

Biological
Brolucizumab 6 mg
3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.
Biological
Aflibercept 2 mg
3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85020
Arizona
United States
Novartis Investigative Site
Recruiting
Phoenix, 85021
Arizona
United States
Novartis Investigative Site
Recruiting
Huntington Beach, 92647
California
United States
Novartis Investigative Site
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Loma Linda, 92354
California
United States
Novartis Investigative Site
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Los Angeles, 90033
California
United States
Novartis Investigative Site
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Riverside, 92505
California
United States
Novartis Investigative Site
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Sacramento, 95817
California
United States
Novartis Investigative Site
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Santa Ana, 92705
California
United States
Novartis Investigative Site
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Torrance, 90505
California
United States
Novartis Investigative Site
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Ventura, 93003
California
United States
Novartis Investigative Site
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Fort Lauderdale, 33309
Florida
United States
Novartis Investigative Site
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Fort Myers, 33912-7125
Florida
United States
Novartis Investigative Site
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Orlando, 32789
Florida
United States
Novartis Investigative Site
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Pinellas Park, 33782
Florida
United States
Novartis Investigative Site
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Winter Haven, 33880
Florida
United States
Novartis Investigative Site
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Atlanta, 30342
Georgia
United States
Novartis Investigative Site
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Springfield, 62704
Illinois
United States
Novartis Investigative Site
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Indianapolis, 46280
Indiana
United States
Novartis Investigative Site
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West Des Moines, 50266
Iowa
United States
Novartis Investigative Site
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Shawnee Mission, 66204
Kansas
United States
Novartis Investigative Site
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Minneapolis, 55435
Minnesota
United States
Novartis Investigative Site
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Kansas City, 64133
Missouri
United States
Novartis Investigative Site
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Hickory, 28602
North Carolina
United States
Novartis Investigative Site
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Portland, 97210
Oregon
United States
Novartis Investigative Site
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Springfield, 97477
Oregon
United States
Novartis Investigative Site
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Germantown, 38138
Tennessee
United States
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Austin, 78705
Texas
United States
Novartis Investigative Site
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Bellaire, 77401
Texas
United States
Novartis Investigative Site
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Fort Worth, 76104
Texas
United States
Novartis Investigative Site
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Harlingen, 78550
Texas
United States
Novartis Investigative Site
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Houston, 77025
Texas
United States
Novartis Investigative Site
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Houston, 77030
Texas
United States
Novartis Investigative Site
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San Antonio, 78240
Texas
United States
Novartis Investigative Site
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Lynchburg, 24502
Virginia
United States
Novartis Investigative Site
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Madison, 53705-3611
Wisconsin
United States
Argentina
Novartis Investigative Site
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Caba, 1116
Buenos Aires
Argentina
Novartis Investigative Site
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Rosario,
Provincia De Santa Fe
Argentina
Novartis Investigative Site
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Caba,
-
Argentina
Novartis Investigative Site
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Ciudad Autonoma de Bs As, C1015ABO
-
Argentina
Australia
Novartis Investigative Site
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Albury, 2640
New South Wales
Australia
Novartis Investigative Site
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Hurstville, 2220
New South Wales
Australia
Novartis Investigative Site
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Parramatta, 2150
New South Wales
Australia
Novartis Investigative Site
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Sydney, 2000
New South Wales
Australia
Novartis Investigative Site
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Southport, 4215
Queensland
Australia
Novartis Investigative Site
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Glen Waverley, 3150
Victoria
Australia
Novartis Investigative Site
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Rowville, 3179
Victoria
Australia
Novartis Investigative Site
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Nedlands, 6009
Western Australia
Australia
Austria
Novartis Investigative Site
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Linz, 4021
Upper Austria
Austria
Novartis Investigative Site
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Vienna, 1090
-
Austria
Novartis Investigative Site
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Wien, A-1140
-
Austria
Belgium
Novartis Investigative Site
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Alken, 3570
-
Belgium
Novartis Investigative Site
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Brussel, 1020
-
Belgium
Novartis Investigative Site
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Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
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Brampton, L6Y 0P6
Ontario
Canada
Novartis Investigative Site
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London, N6A 4G5
Ontario
Canada
Novartis Investigative Site
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Ottawa, K1H 8L6
Ontario
Canada
Novartis Investigative Site
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Toronto, M3C 0G9
Ontario
Canada
Novartis Investigative Site
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Toronto, M4N 3M5
Ontario
Canada
Novartis Investigative Site
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Toronto, M5T 2S8
Ontario
Canada
Novartis Investigative Site
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Boisbriand, J7H 1S6
Quebec
Canada
Novartis Investigative Site
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Quebec, G1S 4L8
-
Canada
Czech Republic
Novartis Investigative Site
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Brno Bohunice, 625 00
Czech Republic
Czech Republic
Novartis Investigative Site
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Zlin, 762 75
Czech Republic
Czech Republic
Novartis Investigative Site
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Hradec Kralove, 500 05
CZE
Czech Republic
Novartis Investigative Site
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Ostrava Poruba, 708 52
-
Czech Republic
Novartis Investigative Site
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Praha 10, 100 34
-
Czech Republic
Novartis Investigative Site
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Praha, 12808
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
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Bonn, 53105
-
Germany
Novartis Investigative Site
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Duesseldorf, 40212
-
Germany
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Freiburg, 79106
-
Germany
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Gottingen, 37075
-
Germany
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Kempten, 87435
-
Germany
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Leipzig, 04103
-
Germany
Novartis Investigative Site
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Mainz, 55131
-
Germany
Novartis Investigative Site
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Muenster, 48145
-
Germany
Novartis Investigative Site
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Muenster, 48149
-
Germany
Novartis Investigative Site
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Ulm, 89075
-
Germany
Israel
Novartis Investigative Site
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Jerusalem, 91120
-
Israel
Novartis Investigative Site
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Ramat Gan, 52621
-
Israel
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Tel Aviv, 64239
-
Israel
Novartis Investigative Site
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Zerifin, 6093000
-
Israel
Italy
Novartis Investigative Site
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Bologna, 40138
BO
Italy
Novartis Investigative Site
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Genova, 16132
GE
Italy
Novartis Investigative Site
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Milano, 20100
MI
Italy
Novartis Investigative Site
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Milano, 20122
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
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Palermo, 90127
PA
Italy
Novartis Investigative Site
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Perugia, 06100
PG
Italy
Novartis Investigative Site
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Novara, 28100
-
Italy
Korea, Republic of
Novartis Investigative Site
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Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Busan, 602739
-
Korea, Republic of
Novartis Investigative Site
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Daegu, 705703
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 05505
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 07301
-
Korea, Republic of
Malaysia
Novartis Investigative Site
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Melaka, 75000
Melaka Malaysia
Malaysia
Novartis Investigative Site
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Batu Caves, 68100
Selangor
Malaysia
Novartis Investigative Site
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Shah Alam, 40000
Selangor
Malaysia
Netherlands
Novartis Investigative Site
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Hertogenbosch, 5200
-
Netherlands
Novartis Investigative Site
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Nijmegen, 6525 EX
-
Netherlands
Novartis Investigative Site
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Zwolle, 8025 AB
-
Netherlands
Portugal
Novartis Investigative Site
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Coimbra, 3000 075
-
Portugal
Novartis Investigative Site
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Porto, 4099-001
-
Portugal
Novartis Investigative Site
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Vila Franca de Xira, 2600-009
-
Portugal
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08022
Cataluna
Spain
Novartis Investigative Site
Recruiting
Sant Cugat, 08190
Catalunya
Spain
Novartis Investigative Site
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Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
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Barcelona, 08024
-
Spain
Novartis Investigative Site
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Barcelona, 08025
-
Spain
Novartis Investigative Site
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Cordoba, 14012
-
Spain
Novartis Investigative Site
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Valencia, 46004
-
Spain
Novartis Investigative Site
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Zaragoza, 50009
-
Spain
Switzerland
Novartis Investigative Site
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Lausanne, 1000
CHE
Switzerland
Novartis Investigative Site
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Bern, 3010
-
Switzerland
Novartis Investigative Site
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Binningen, 4102
-
Switzerland
Taiwan
Novartis Investigative Site
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Taipei, 10449
-
Taiwan
Novartis Investigative Site
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Taipei, 11217
-
Taiwan
Novartis Investigative Site
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Taipei,
-
Taiwan
Novartis Investigative Site
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Taoyuan, 33305
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
Bradford, BD9 6RJ
West Yorkshire
United Kingdom
Novartis Investigative Site
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London, EC1V 2PD
-
United Kingdom
Novartis Investigative Site
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Norwich, NR4 7UY
-
United Kingdom
Novartis Investigative Site
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Rugby, CV22 5PX
-
United Kingdom
Novartis Investigative Site
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Sunderland, SR2 9HP
-
United Kingdom
Novartis Investigative Site
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Torquay, TQ2 7AA
-
United Kingdom
Novartis Investigative Site
Recruiting
Wolverhampton, WV10 0QP
-
United Kingdom

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Phone: 
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