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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)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04005352
Collaborator
(none)
739
Enrollment
118
Locations
2
Arms
34.8
Anticipated Duration (Months)
6.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Brolucizumab 6 mg
  • Biological: Aflibercept 2 mg
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
739 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double arm, multi-centerDouble arm, multi-center
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 25, 2019
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Aug 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brolucizumab

Intra-vitreal injection

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.
Other Names:
  • RTH258

    		•
    Active Comparator: Aflibercept

    Intra-vitreal injection

    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
    Other Names:
  • EYLEA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average change in Best-corrected visual acuity [At Weeks 28 and 32]

      Visual acuity test

    2. Distribution of the last interval with no disease activity [Up to Week 32]

      Treatment interval distribution

    Secondary Outcome Measures

    1. Distribution of the last interval with no disease activity [Up to Week 64]

      Treatment interval distribution

    2. Distribution of the maximal intervals with no disease activity [Up to Week 64]

      Treatment interval distribution

    3. Proportion of patients with no disease activit [At Weeks 14 and 16]

      Disease activity assessment

    4. Time from the last loading injection to the first visit with no disease activity [Week 8 to week 62]

      Disease activity assessment

    5. Average change in Best-corrected visual acuity [At Weeks 60 and 64]

      Visual acuity test

    6. Occurrence of Best-corrected visual acuity improvements of ≥ 10 and ≥ 15 letters [At Week 32, Week 64, and at the last injection visit]

      Visual acuity test

    7. Occurrence of Best-corrected visual acuity ≥ 69 letters [At Week 32, at Week 64, and at the last injection visit]

      Visual acuity test

    8. Average change from baseline in Central Subfield Thickness [At Weeks 28 and 32]

      Spectral Domain Optical Coherence Tomography

    9. Average change from baseline in Central Subfield Thickness [At Weeks 60 and 64]

      Spectral Domain Optical Coherence Tomography

    10. Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield [At Weeks 28 and 32]

      Spectral Domain Optical Coherence Tomography

    11. Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield [At Weeks 60 and 64]

      Spectral Domain Optical Coherence Tomography

    12. Change in Visual Function Questionnnaire-25 [At Weeks 32 and 64]

      Visual Function Questionnnaire-25

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Phoenix Arizona United States 85020
    2 Novartis Investigative Site Huntington Beach California United States 92647
    3 Novartis Investigative Site Loma Linda California United States 92354
    4 Novartis Investigative Site Riverside California United States 92505
    5 Novartis Investigative Site Santa Ana California United States 92705
    6 Novartis Investigative Site Fort Lauderdale Florida United States 33309
    7 Novartis Investigative Site Fort Myers Florida United States 33912-7125
    8 Novartis Investigative Site Orlando Florida United States 32789
    9 Novartis Investigative Site Pinellas Park Florida United States 33782
    10 Novartis Investigative Site Winter Haven Florida United States 33880
    11 Novartis Investigative Site Springfield Illinois United States 62704
    12 Novartis Investigative Site Indianapolis Indiana United States 46280
    13 Novartis Investigative Site West Des Moines Iowa United States 50266
    14 Novartis Investigative Site Minneapolis Minnesota United States 55435
    15 Novartis Investigative Site Hickory North Carolina United States 28602
    16 Novartis Investigative Site Portland Oregon United States 97210
    17 Novartis Investigative Site Springfield Oregon United States 97477
    18 Novartis Investigative Site Germantown Tennessee United States 38138
    19 Novartis Investigative Site Austin Texas United States 78705
    20 Novartis Investigative Site Bellaire Texas United States 77401
    21 Novartis Investigative Site Fort Worth Texas United States 76104
    22 Novartis Investigative Site Houston Texas United States 77025
    23 Novartis Investigative Site Houston Texas United States 77030
    24 Novartis Investigative Site San Antonio Texas United States 78240
    25 Novartis Investigative Site Caba Buenos Aires Argentina 1116
    26 Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires Argentina C1015ABO
    27 Novartis Investigative Site Rosario Provincia De Santa Fe Argentina
    28 Novartis Investigative Site Caba Argentina
    29 Novartis Investigative Site Albury New South Wales Australia 2640
    30 Novartis Investigative Site Hurstville New South Wales Australia 2220
    31 Novartis Investigative Site Parramatta New South Wales Australia 2150
    32 Novartis Investigative Site Sydney New South Wales Australia 2000
    33 Novartis Investigative Site Southport Queensland Australia 4215
    34 Novartis Investigative Site Glen Waverley Victoria Australia 3150
    35 Novartis Investigative Site Rowville Victoria Australia 3179
    36 Novartis Investigative Site Nedlands Western Australia Australia 6009
    37 Novartis Investigative Site Vienna Austria 1090
    38 Novartis Investigative Site Wien Austria 1140
    39 Novartis Investigative Site Alken Belgium 3570
    40 Novartis Investigative Site Leuven Belgium 3000
    41 Novartis Investigative Site Brampton Ontario Canada L6Y 0P6
    42 Novartis Investigative Site London Ontario Canada N6A 4G5
    43 Novartis Investigative Site Toronto Ontario Canada M4N 3M5
    44 Novartis Investigative Site Boisbriand Quebec Canada J7H 1S6
    45 Novartis Investigative Site Quebec Canada G1S 4L8
    46 Novartis Investigative Site Zlin Czech Republic Czechia 762 75
    47 Novartis Investigative Site Hradec Kralove CZE Czechia 500 05
    48 Novartis Investigative Site Ostrava Poruba Czechia 708 52
    49 Novartis Investigative Site Praha 10 Czechia 100 34
    50 Novartis Investigative Site Praha Czechia 12808
    51 Novartis Investigative Site Saint Cyr sur Loire Indre Et Loire France 37540
    52 Novartis Investigative Site Bordeaux France 33000
    53 Novartis Investigative Site Creteil France 94000
    54 Novartis Investigative Site Lyon Cedex 04 France 69317
    55 Novartis Investigative Site Marseille France F 13008
    56 Novartis Investigative Site Montauban France 82000
    57 Novartis Investigative Site Nantes Cedex 1 France 44093
    58 Novartis Investigative Site Paris cedex 10 France 75010
    59 Novartis Investigative Site Paris France 75015
    60 Novartis Investigative Site Rueil Malmaison France 92500
    61 Novartis Investigative Site Strasbourg France 67000
    62 Novartis Investigative Site Berlin Germany 10713
    63 Novartis Investigative Site Bonn Germany 53105
    64 Novartis Investigative Site Duesseldorf Germany 40212
    65 Novartis Investigative Site Freiburg Germany 79106
    66 Novartis Investigative Site Gottingen Germany 37075
    67 Novartis Investigative Site Kempten Germany 87435
    68 Novartis Investigative Site Leipzig Germany 04103
    69 Novartis Investigative Site Mainz Germany 55131
    70 Novartis Investigative Site Muenster Germany 48145
    71 Novartis Investigative Site Muenster Germany 48149
    72 Novartis Investigative Site Ulm Germany 89075
    73 Novartis Investigative Site Jerusalem Israel 9112001
    74 Novartis Investigative Site Ramat Gan Israel 52621
    75 Novartis Investigative Site Tel Aviv Israel 64239
    76 Novartis Investigative Site Zerifin Israel 6093000
    77 Novartis Investigative Site Bologna BO Italy 40138
    78 Novartis Investigative Site Genova GE Italy 16132
    79 Novartis Investigative Site Milano MI Italy 20100
    80 Novartis Investigative Site Milano MI Italy 20122
    81 Novartis Investigative Site Palermo PA Italy 90127
    82 Novartis Investigative Site Perugia PG Italy 06100
    83 Novartis Investigative Site Novara Italy 28100
    84 Novartis Investigative Site Bundang Gu Gyeonggi Do Korea, Republic of 13620
    85 Novartis Investigative Site Seoul Seocho Gu Korea, Republic of 06591
    86 Novartis Investigative Site Busan Korea, Republic of 602739
    87 Novartis Investigative Site Daegu Korea, Republic of 705703
    88 Novartis Investigative Site Seoul Korea, Republic of 05505
    89 Novartis Investigative Site Seoul Korea, Republic of 07301
    90 Novartis Investigative Site Melaka Melaka Malaysia Malaysia 75000
    91 Novartis Investigative Site Batu Caves Selangor Malaysia 68100
    92 Novartis Investigative Site Shah Alam Selangor Malaysia 40000
    93 Novartis Investigative Site Hertogenbosch Netherlands 5200
    94 Novartis Investigative Site Nijmegen Netherlands 6525 EX
    95 Novartis Investigative Site Coimbra Portugal 3000 075
    96 Novartis Investigative Site Porto Portugal 4099-001
    97 Novartis Investigative Site Vila Franca de Xira Portugal 2600-009
    98 Novartis Investigative Site Barcelona Cataluna Spain 08022
    99 Novartis Investigative Site Sant Cugat Catalunya Spain 08190
    100 Novartis Investigative Site Pamplona Navarra Spain 31008
    101 Novartis Investigative Site Burjassot Valencia Spain 46100
    102 Novartis Investigative Site Barcelona Spain 08024
    103 Novartis Investigative Site Barcelona Spain 08025
    104 Novartis Investigative Site Cordoba Spain 14012
    105 Novartis Investigative Site Zaragoza Spain 50009
    106 Novartis Investigative Site Oerebro Sweden 701 85
    107 Novartis Investigative Site Vasteras Sweden 72189
    108 Novartis Investigative Site Binningen Switzerland 4102
    109 Novartis Investigative Site Taipei Taiwan 10449
    110 Novartis Investigative Site Taipei Taiwan 11217
    111 Novartis Investigative Site Taipei Taiwan
    112 Novartis Investigative Site Taoyuan Taiwan 33305
    113 Novartis Investigative Site Bradford West Yorkshire United Kingdom BD9 6RJ
    114 Novartis Investigative Site London United Kingdom EC1V 2PD
    115 Novartis Investigative Site Rugby United Kingdom CV22 5PX
    116 Novartis Investigative Site Sunderland United Kingdom SR2 9HP
    117 Novartis Investigative Site Torquay United Kingdom TQ2 7AA
    118 Novartis Investigative Site Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04005352
    Other Study ID Numbers:
    • CRTH258A2303
    • 2019-000716-28
    First Posted:
    Jul 2, 2019
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    AMD, nAMD, wet AMD, RTH258, brolucizumab, double blind
    Additional relevant MeSH terms:
    Macular Degeneration
    Eye Diseases
    Retinal Diseases
    Retinal Degeneration
    Wet Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Jul 18, 2022