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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04005352
Ethics application status
Date submitted
1/07/2019
Date registered
2/07/2019

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
2019-000716-28
Secondary ID [2] 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
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

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

Experimental: 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.

Active comparator: 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


Treatment: Other: Brolucizumab 6 mg
Intra-vitreal injection

Treatment: Other: Aflibercept 2 mg
Intra-vitreal injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye
Timepoint [1] 0 0
Up to Week 32
Primary outcome [2] 0 0
Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye
Timepoint [2] 0 0
Baseline, Week 28 and Week 32
Secondary outcome [1] 0 0
Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye
Timepoint [1] 0 0
Up to Week 64
Secondary outcome [2] 0 0
Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye
Timepoint [2] 0 0
Up to Week 64
Secondary outcome [3] 0 0
Number of Participants With no Disease Activity - Study Eye
Timepoint [3] 0 0
Weeks 14 and 16
Secondary outcome [4] 0 0
Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye
Timepoint [4] 0 0
Up to Week 64
Secondary outcome [5] 0 0
Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye
Timepoint [5] 0 0
Up to Week 64
Secondary outcome [6] 0 0
Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye
Timepoint [6] 0 0
Baseline, Week 60 and Week 64
Secondary outcome [7] 0 0
Number of Participants With Best-corrected Visual Acuity Improvements of = 15 Letters in BCVA From Baseline or Reached BCVA = 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye
Timepoint [7] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [8] 0 0
Number of Participants With Best-corrected Visual Acuity = 69 Letters - Study Eye
Timepoint [8] 0 0
Week 32 and Week 64
Secondary outcome [9] 0 0
Average Change From Baseline in Central Subfield Thickness (CSFT) - Study Eye
Timepoint [9] 0 0
Baseline, Weeks 28 and 32 and at Weeks 60 and 64
Secondary outcome [10] 0 0
Number of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study Eye
Timepoint [10] 0 0
At Weeks 28, 32, 60 and 64
Secondary outcome [11] 0 0
Number of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study Eye
Timepoint [11] 0 0
At Weeks 28, 32, 60 and 64
Secondary outcome [12] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study Eye
Timepoint [12] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [13] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study Eye
Timepoint [13] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [14] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study Eye
Timepoint [14] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [15] 0 0
Change From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study Eye
Timepoint [15] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [16] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study Eye
Timepoint [16] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [17] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study Eye
Timepoint [17] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [18] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study Eye
Timepoint [18] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [19] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Role Difficulties - Study Eye
Timepoint [19] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [20] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Dependency - Study Eye
Timepoint [20] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [21] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Driving - Study Eye
Timepoint [21] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [22] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Color Vision - Study Eye
Timepoint [22] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [23] 0 0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Peripheral Vision - Study Eye
Timepoint [23] 0 0
Baseline, Week 32, and Week 64
Secondary outcome [24] 0 0
Number of Participants With Treatment Emergent Ocular Adverse Events (Greater Than or Equal to 1% in Any Treatment Arm) by Preferred Term for the Study Eye
Timepoint [24] 0 0
Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years.
Secondary outcome [25] 0 0
Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table
Timepoint [25] 0 0
Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years.

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
Sex
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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2022
Sample size
Target
Accrual to date
Final
734
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
De Santa Fe
Country [14] 0 0
Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Alken
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Czech Republic
Country [22] 0 0
Czechia
State/province [22] 0 0
CZE
Country [23] 0 0
Czechia
State/province [23] 0 0
Ostrava Poruba
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 10
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha
Country [26] 0 0
France
State/province [26] 0 0
Indre Et Loire
Country [27] 0 0
France
State/province [27] 0 0
Rhone
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Creteil
Country [30] 0 0
France
State/province [30] 0 0
Marseille
Country [31] 0 0
France
State/province [31] 0 0
Montauban
Country [32] 0 0
France
State/province [32] 0 0
Nantes Cedex 1
Country [33] 0 0
France
State/province [33] 0 0
Paris cedex 10
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Rueil Malmaison
Country [36] 0 0
France
State/province [36] 0 0
Strasbourg
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Bonn
Country [39] 0 0
Germany
State/province [39] 0 0
Duesseldorf
Country [40] 0 0
Germany
State/province [40] 0 0
Freiburg
Country [41] 0 0
Germany
State/province [41] 0 0
Gottingen
Country [42] 0 0
Germany
State/province [42] 0 0
Kempten
Country [43] 0 0
Germany
State/province [43] 0 0
Leipzig
Country [44] 0 0
Germany
State/province [44] 0 0
Mainz
Country [45] 0 0
Germany
State/province [45] 0 0
Muenster
Country [46] 0 0
Germany
State/province [46] 0 0
Ulm
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Ramat Gan
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Israel
State/province [50] 0 0
Zerifin
Country [51] 0 0
Italy
State/province [51] 0 0
BO
Country [52] 0 0
Italy
State/province [52] 0 0
GE
Country [53] 0 0
Italy
State/province [53] 0 0
MI
Country [54] 0 0
Italy
State/province [54] 0 0
PA
Country [55] 0 0
Italy
State/province [55] 0 0
PG
Country [56] 0 0
Italy
State/province [56] 0 0
Novara
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Gyeonggi Do
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seocho Gu
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Busan
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Korea, Republic of
State/province [60] 0 0
Daegu
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Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Malaysia
State/province [62] 0 0
Melaka Malaysia
Country [63] 0 0
Malaysia
State/province [63] 0 0
Selangor
Country [64] 0 0
Netherlands
State/province [64] 0 0
Hertogenbosch
Country [65] 0 0
Netherlands
State/province [65] 0 0
Nijmegen
Country [66] 0 0
Portugal
State/province [66] 0 0
Coimbra
Country [67] 0 0
Portugal
State/province [67] 0 0
Porto
Country [68] 0 0
Portugal
State/province [68] 0 0
Vila Franca de Xira
Country [69] 0 0
Spain
State/province [69] 0 0
Cataluna
Country [70] 0 0
Spain
State/province [70] 0 0
Catalunya
Country [71] 0 0
Spain
State/province [71] 0 0
Navarra
Country [72] 0 0
Spain
State/province [72] 0 0
Valencia
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Cordoba
Country [75] 0 0
Spain
State/province [75] 0 0
Zaragoza
Country [76] 0 0
Sweden
State/province [76] 0 0
Oerebro
Country [77] 0 0
Sweden
State/province [77] 0 0
Vasteras
Country [78] 0 0
Switzerland
State/province [78] 0 0
Binningen
Country [79] 0 0
Taiwan
State/province [79] 0 0
Taipei
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taoyuan
Country [81] 0 0
United Kingdom
State/province [81] 0 0
West Yorkshire
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Rugby
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Sunderland
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Torquay
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04005352