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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04005352




Registration number
NCT04005352
Ethics application status
Date submitted
1/07/2019
Date registered
2/07/2019
Date last updated
18/09/2020

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
Scientific 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)
Secondary ID [1] 0 0
CRTH258A2303
Universal Trial Number (UTN)
Trial acronym
TALON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration 0 0
Macular Degeneration 0 0
Wet Macular Degeneration 0 0
Retinal Degeneration 0 0
Retinal Diseases 0 0
Eye Diseases 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Brolucizumab 6 mg
Other interventions - Aflibercept 2 mg

Experimental: Brolucizumab - Intra-vitreal injection

Active Comparator: Aflibercept - Intra-vitreal injection


Other interventions: 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.

Other interventions: 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average change in Best-corrected visual acuity - Visual acuity test
Timepoint [1] 0 0
At Weeks 28 and 32
Primary outcome [2] 0 0
Distribution of the last interval with no disease activity - Treatment interval distribution
Timepoint [2] 0 0
Up to Week 32
Secondary outcome [1] 0 0
Distribution of the last interval with no disease activity - Treatment interval distribution
Timepoint [1] 0 0
Up to Week 64
Secondary outcome [2] 0 0
Distribution of the maximal intervals with no disease activity - Treatment interval distribution
Timepoint [2] 0 0
Up to Week 64
Secondary outcome [3] 0 0
Proportion of patients with no disease activit - Disease activity assessment
Timepoint [3] 0 0
At Weeks 14 and 16
Secondary outcome [4] 0 0
Time from the last loading injection to the first visit with no disease activity - Disease activity assessment
Timepoint [4] 0 0
Week 8 to week 62
Secondary outcome [5] 0 0
Average change in Best-corrected visual acuity - Visual acuity test
Timepoint [5] 0 0
At Weeks 60 and 64
Secondary outcome [6] 0 0
Occurrence of Best-corrected visual acuity improvements of = 10 and = 15 letters - Visual acuity test
Timepoint [6] 0 0
At Week 32, Week 64, and at the last injection visit
Secondary outcome [7] 0 0
Occurrence of Best-corrected visual acuity = 69 letters - Visual acuity test
Timepoint [7] 0 0
At Week 32, at Week 64, and at the last injection visit
Secondary outcome [8] 0 0
Average change from baseline in Central Subfield Thickness - Spectral Domain Optical Coherence Tomography
Timepoint [8] 0 0
At Weeks 28 and 32
Secondary outcome [9] 0 0
Average change from baseline in Central Subfield Thickness - Spectral Domain Optical Coherence Tomography
Timepoint [9] 0 0
At Weeks 60 and 64
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
At Weeks 28 and 32
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
At Weeks 60 and 64
Secondary outcome [12] 0 0
Change in Visual Function Questionnnaire-25 - Visual Function Questionnnaire-25
Timepoint [12] 0 0
At Weeks 32 and 64

Eligibility
Key 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)
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Albury
Recruitment hospital [2] 0 0
Novartis Investigative Site - Hurstville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [4] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [5] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [6] 0 0
Novartis Investigative Site - Glen Waverley
Recruitment hospital [7] 0 0
Novartis Investigative Site - Rowville
Recruitment hospital [8] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [7] 0 0
3179 - Rowville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Austria
State/province [6] 0 0
Upper Austria
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Belgium
State/province [8] 0 0
Alken
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussel
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Czechia
State/province [11] 0 0
CZE
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 10
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha
Country [14] 0 0
France
State/province [14] 0 0
Indre Et Loire
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Creteil
Country [17] 0 0
France
State/province [17] 0 0
Lyon Cedex 04
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Montauban
Country [20] 0 0
France
State/province [20] 0 0
Nantes Cedex 1
Country [21] 0 0
France
State/province [21] 0 0
Paris cedex 10
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Rueil Malmaison
Country [24] 0 0
France
State/province [24] 0 0
Strasbourg
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Düsseldorf
Country [27] 0 0
Germany
State/province [27] 0 0
Freiburg
Country [28] 0 0
Germany
State/province [28] 0 0
Kempten
Country [29] 0 0
Germany
State/province [29] 0 0
Leipzig
Country [30] 0 0
Germany
State/province [30] 0 0
Mainz
Country [31] 0 0
Germany
State/province [31] 0 0
Muenster
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Israel
State/province [33] 0 0
Ramat Gan
Country [34] 0 0
Israel
State/province [34] 0 0
Zerifin
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Gyeonggi Do
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seocho Gu
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Busan
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Daegu
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul
Country [40] 0 0
Malaysia
State/province [40] 0 0
Melaka Malaysia
Country [41] 0 0
Malaysia
State/province [41] 0 0
Selangor
Country [42] 0 0
Netherlands
State/province [42] 0 0
Hertogenbosch
Country [43] 0 0
Netherlands
State/province [43] 0 0
Nijmegen
Country [44] 0 0
Netherlands
State/province [44] 0 0
Zwolle
Country [45] 0 0
Portugal
State/province [45] 0 0
Coimbra
Country [46] 0 0
Portugal
State/province [46] 0 0
Porto
Country [47] 0 0
Portugal
State/province [47] 0 0
Vila Franca de Xira
Country [48] 0 0
Spain
State/province [48] 0 0
Catalunya
Country [49] 0 0
Spain
State/province [49] 0 0
Cataluña
Country [50] 0 0
Spain
State/province [50] 0 0
Navarra
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Cordoba
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Spain
State/province [54] 0 0
Zaragoza
Country [55] 0 0
Sweden
State/province [55] 0 0
Oerebro
Country [56] 0 0
Sweden
State/province [56] 0 0
Vasteras
Country [57] 0 0
Switzerland
State/province [57] 0 0
CHE
Country [58] 0 0
Switzerland
State/province [58] 0 0
Bern
Country [59] 0 0
Switzerland
State/province [59] 0 0
Binningen
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taipei
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04005352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04005352