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

See if you pre-qualify

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 
Oct 04, 2022
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
Huntington Beach, 92647
California
United States
Novartis Investigative Site
Recruiting
Sacramento, 95817
California
United States
Novartis Investigative Site
Recruiting
Ventura, 93003
California
United States
Novartis Investigative Site
Withdrawn
Bloomington, 61704
Illinois
United States
Novartis Investigative Site
Withdrawn
Chicago, 60657
Illinois
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46280
Indiana
United States
Novartis Investigative Site
Recruiting
Minneapolis, 55435
Minnesota
United States
Novartis Investigative Site
Recruiting
Austin, 78705
Texas
United States
Novartis Investigative Site
Recruiting
Fort Worth, 76104
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78240
Texas
United States
Australia
Novartis Investigative Site
Recruiting
Albury, 2640
New South Wales
Australia
Novartis Investigative Site
Recruiting
Hurstville, 2220
New South Wales
Australia
Novartis Investigative Site
Recruiting
Parramatta, 2150
New South Wales
Australia
Novartis Investigative Site
Recruiting
Sydney, 2000
New South Wales
Australia
Novartis Investigative Site
Recruiting
Southport, 4215
Queensland
Australia
Novartis Investigative Site
Recruiting
Glen Waverley, 3150
Victoria
Australia
Novartis Investigative Site
Recruiting
Rowville, 3179
Victoria
Australia
Novartis Investigative Site
Recruiting
Nedlands, 6009
Western Australia
Australia
Austria
Novartis Investigative Site
Recruiting
Linz, 4021
Upper Austria
Austria
Novartis Investigative Site
Recruiting
Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Alken, 3570
-
Belgium
Novartis Investigative Site
Recruiting
Brussel, 1020
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Czechia
Novartis Investigative Site
Recruiting
Hradec Kralove, 500 05
CZE
Czechia
Novartis Investigative Site
Recruiting
Praha 10, 100 34
-
Czechia
Novartis Investigative Site
Recruiting
Praha, 12808
-
Czechia
France
Novartis Investigative Site
Recruiting
Saint Cys Sur Loire, 37540
Indre Et Loire
France
Novartis Investigative Site
Recruiting
Bordeaux, 33000
-
France
Novartis Investigative Site
Recruiting
Creteil, 94000
-
France
Novartis Investigative Site
Recruiting
Lyon Cedex 04, 69317
-
France
Novartis Investigative Site
Recruiting
Marseille, F 13008
-
France
Novartis Investigative Site
Recruiting
Montauban, 82000
-
France
Novartis Investigative Site
Recruiting
Nantes Cedex 1, 44093
-
France
Novartis Investigative Site
Recruiting
Paris cedex 10, 75010
-
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Novartis Investigative Site
Recruiting
Rueil Malmaison, 92500
-
France
Novartis Investigative Site
Recruiting
Strasbourg, 67000
-
France
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Düsseldorf, 40212
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Kempten, 87435
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48145
-
Germany
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 91120
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Zerifin, 6093000
-
Israel
Korea, Republic of
Novartis Investigative Site
Recruiting
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Busan, 602739
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu, 705703
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 07301
-
Korea, Republic of
Malaysia
Novartis Investigative Site
Recruiting
Melaka, 75000
Melaka Malaysia
Malaysia
Novartis Investigative Site
Recruiting
Batu Caves, 68100
Selangor
Malaysia
Novartis Investigative Site
Recruiting
Shah Alam, 40000
Selangor
Malaysia
Netherlands
Novartis Investigative Site
Recruiting
Hertogenbosch, 5200
-
Netherlands
Novartis Investigative Site
Recruiting
Nijmegen, 6525 EX
-
Netherlands
Novartis Investigative Site
Recruiting
Zwolle, 8025 AB
-
Netherlands
Portugal
Novartis Investigative Site
Recruiting
Coimbra, 3000 075
-
Portugal
Novartis Investigative Site
Recruiting
Porto, 4099-001
-
Portugal
Novartis Investigative Site
Recruiting
Vila Franca de Xira, 2600-009
-
Portugal
Spain
Novartis Investigative Site
Recruiting
Sant Cugat, 08190
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08022
Cataluña
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08025
-
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14012
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46004
-
Spain
Novartis Investigative Site
Recruiting
Zaragoza, 50009
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Oerebro, 701 85
-
Sweden
Novartis Investigative Site
Recruiting
Vasteras, 72189
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1000
CHE
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Binningen, 4102
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10449
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei,
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]