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TALON Ext: An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04597632
Collaborator
(none)
255
Enrollment
60
Locations
1
Arm
27.4
Anticipated Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.

The study period is 56 weeks including post-treatment follow-up.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study is a 56-week, open-label, one-arm extension study in participants who have completed the CRTH258A2303 study (TALON). Participants who consent and meet all the inclusion and none of the exclusion criteria will be enrolled into this extension study and receive brolucizumab 6 mg in a TtC regimen, irrespective of the treatment received in the core study.

It is estimated that 622 participants from the core study will enter the extension study (10% dropout rate expected). The maximum study duration for one participant is 56 weeks, including post-treatment follow-up.

There will be two periods in this study:

  • Treat-to-Control treatment period: from Baseline (Day 1) to Week 52

  • Post-treatment follow-up period: from Week 52 to Week 56.

All participants will be treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).

Treatment intervals can then be extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. The treatment intervals should be by 4 weeks at a time if disease activity recurs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
255 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
Actual Study Start Date :
Dec 16, 2020
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: brolucizumab 6 mg

Participants will receive brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals may be changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity.

Drug: brolucizumab
brolucizumab 6 mg/0.05 mL solution for intravitreal injection
Other Names:
  • RTH258

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Extended durability of brolucizumab in a Treat-to-Control regimen [56 weeks]

      Duration of the last interval with no disease activity up to week 56

    2. Functional outcomes of brolucizumab in a Treat-to-Control regimen [Baseline, 52 and 56 weeks]

      Change in BCVA from baseline at Week 52 and Week 56

    Secondary Outcome Measures

    1. Anatomical outcome of brolucizumab in all patients - as measured by the change in central subfield thickness [Baseline, 52 and 56 weeks]

      Change in central subfield thickness from baseline to Week 52 and Week 56

    2. Anatomical outcome of brolucizumab in all patients - as assessed by spectral domain ocular coherence tomography [Baseline, 52 and 56 weeks]

      Number of visits with presence of intraretinal fluid and/or subretinal fluid, and sub-retinal pigment epithelium fluid in the central subfield, as assessed by spectral domain ocular coherence tomography at week 52 and week 56

    3. Durability of brolucizumab in all patients - as measured by duration of the last interval with no disease activity [Baseline and week 56]

      Duration of the last interval with no disease activity up to week 56

    4. Durability of brolucizumab in all patients - as measured by duration of the maximal intervals with no disease activity [Baseline and week 56]

      Duration of the maximal intervals with no disease activity up to week 56

    5. Durability of brolucizumab in all patients - as measured by change of the duration of last interval with no disease activity [Baseline and week 56]

      Change of the duration of last interval with no disease activity between baseline and week 56

    6. Functional outcomes of brolucizumab per randomized arm in the core study [Baseline, 52 and 56 weeks]

      Change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 and week 56

    7. Safety of brolucizumab - as measured by the indicence of ocular and non ocular Adverse Events (AEs) [up to Week 56]

      Occurrence of Ocular and Non-ocular AEs up to Week 56

    Eligibility Criteria

    Criteria

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

    1. Signed informed consent

    2. Successfully completed TALON core study at week 64 (End of Study)

    Exclusion Criteria:

    1. Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator

    2. Discontinued study treatment in the core study

    3. Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.

    4. Pregnant or nursing (lactating) women

    5. Women of child-bearing potential not using highly effective methods of contraception

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Huntington Beach California United States 92647
    2 Novartis Investigative Site Fort Lauderdale Florida United States 33309
    3 Novartis Investigative Site Indianapolis Indiana United States 46280
    4 Novartis Investigative Site Minneapolis Minnesota United States 55435
    5 Novartis Investigative Site Germantown Tennessee United States 38138
    6 Novartis Investigative Site Albury New South Wales Australia 2640
    7 Novartis Investigative Site Hurstville New South Wales Australia 2220
    8 Novartis Investigative Site Parramatta New South Wales Australia 2150
    9 Novartis Investigative Site Sydney New South Wales Australia 2000
    10 Novartis Investigative Site Glen Waverley Victoria Australia 3150
    11 Novartis Investigative Site Rowville Victoria Australia 3179
    12 Novartis Investigative Site Nedlands Western Australia Australia 6009
    13 Novartis Investigative Site Hasselt Belgium 3500
    14 Novartis Investigative Site Hradec Kralove CZE Czechia 500 05
    15 Novartis Investigative Site Praha 10 Czechia 100 34
    16 Novartis Investigative Site Praha Czechia 12808
    17 Novartis Investigative Site Saint Cyr sur Loire Indre Et Loire France 37540
    18 Novartis Investigative Site Bordeaux France 33000
    19 Novartis Investigative Site Creteil France 94000
    20 Novartis Investigative Site Lyon Cedex 04 France 69317
    21 Novartis Investigative Site Marseille France F 13008
    22 Novartis Investigative Site Montauban France 82000
    23 Novartis Investigative Site Nantes Cedex 1 France 44093
    24 Novartis Investigative Site Paris cedex 10 France 75010
    25 Novartis Investigative Site Paris France 75015
    26 Novartis Investigative Site Rueil Malmaison France 92500
    27 Novartis Investigative Site Freiburg Germany 79106
    28 Novartis Investigative Site Leipzig Germany 04103
    29 Novartis Investigative Site Mainz Germany 55131
    30 Novartis Investigative Site Jerusalem Israel 9112001
    31 Novartis Investigative Site Ramat Gan Israel 52621
    32 Novartis Investigative Site Zerifin Israel 6093000
    33 Novartis Investigative Site Perugia PG Italy 06100
    34 Novartis Investigative Site Bundang Gu Gyeonggi Do Korea, Republic of 13620
    35 Novartis Investigative Site Seoul Seocho Gu Korea, Republic of 06591
    36 Novartis Investigative Site Busan Korea, Republic of 602739
    37 Novartis Investigative Site Daegu Korea, Republic of 705703
    38 Novartis Investigative Site Seoul Korea, Republic of 05505
    39 Novartis Investigative Site Seoul Korea, Republic of 07301
    40 Novartis Investigative Site Melaka Melaka Malaysia Malaysia 75000
    41 Novartis Investigative Site Batu Caves Selangor Malaysia 68100
    42 Novartis Investigative Site Shah Alam Selangor Malaysia 40000
    43 Novartis Investigative Site Den Bosch Netherlands 5223 GZ
    44 Novartis Investigative Site Nijmegen Netherlands 6525 EX
    45 Novartis Investigative Site Porto Portugal 4099-001
    46 Novartis Investigative Site Vila Franca de Xira Portugal 2600-009
    47 Novartis Investigative Site Barcelona Cataluna Spain 08022
    48 Novartis Investigative Site Sant Cugat Catalunya Spain 08190
    49 Novartis Investigative Site Pamplona Navarra Spain 31008
    50 Novartis Investigative Site Burjassot Valencia Spain 46100
    51 Novartis Investigative Site Barcelona Spain 08024
    52 Novartis Investigative Site Barcelona Spain 08025
    53 Novartis Investigative Site Cordoba Spain 14012
    54 Novartis Investigative Site Zaragoza Spain 50009
    55 Novartis Investigative Site Oerebro Sweden 701 85
    56 Novartis Investigative Site Vasteras Sweden 72189
    57 Novartis Investigative Site Binningen Switzerland 4102
    58 Novartis Investigative Site Taipei Taiwan 11217
    59 Novartis Investigative Site Taipei Taiwan
    60 Novartis Investigative Site Taoyuan Taiwan 33305

    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:
    NCT04597632
    Other Study ID Numbers:
    • CRTH258A2303E1
    • 2020-002349-40
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 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
    neovascular age-related macular degeneration
    wet age-related macular degeneration
    wet AMD
    choroidal neovascularization
    individualized treatment
    anti-VEGF
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration

    Study Results

    No Results Posted as of Aug 22, 2022