Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

Last updated: October 7, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Macular Degeneration

Aging

Retina

Treatment

Brolucizumab 6 mg

Aflibercept 2 mg

Clinical Study ID

NCT04005352
CRTH258A2303
2019-000716-28
  • Ages > 50
  • All Genders

Study Summary

This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.

Eligibility Criteria

Inclusion

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 centralsubfield, including retinal angiomatous proliferation (RAP) with a CNV component,confirmed by presence of active leakage from CNV seen by fluorescein angiography andsequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal orsub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macularedema (study eye)

  • Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects thecentral 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 testingcharts at both screening and baseline visit (study eye)

Exclusion

Exclusion Criteria:

  • Ocular conditions/disorders at screening or baseline which could, in the opinion ofthe investigator, prevent response to study treatment or may confound interpretationof study results, compromise visual acuity or require planned medical or surgicalintervention 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 growthfactor (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

Total Participants: 734
Treatment Group(s): 2
Primary Treatment: Brolucizumab 6 mg
Phase: 3
Study Start date:
September 25, 2019
Estimated Completion Date:
September 09, 2022

Study Description

At the baseline Visit, subjects who met the eligibility criteria were randomized in a 1:1 ratio to receive either: -Brolucizumab 6 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

-Aflibercept 2 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to-Control treatment from Week 16 up to Week 60/62.

For all subjects, the last potential study treatment was at the Week 60 visit (or at the Week 62 visit for subjects whose actual treatment interval would require a treatment at Week 62). The initiation phase starts on Day 1 and ends on Week 16. Treat to Control regimen starts on Week 16 until end of treatment (Week 60/62).

In both treatment arms, treatment intervals after the initiation phase were either 8 weeks, 12 weeks, or 16 weeks. Per the original protocol, if it was determined that a patient required more frequent injections than q8w, he/she would be moved to a q4w treatment interval. However, this option was removed per Protocol amendment 02, after which, dosing intervals shorter than q8w were not permitted.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario, De Santa Fe B7602
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Caba, C1056
    Argentina

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  • Novartis Investigative Site

    Albury, New South Wales 2640
    Australia

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  • Novartis Investigative Site

    Hurstville, New South Wales 2220
    Australia

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    Parramatta, New South Wales 2150
    Australia

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    Sydney, New South Wales 2000
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    Southport, Queensland 4215
    Australia

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    Glen Waverley, Victoria 3150
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    Rowville, Victoria 3179
    Australia

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    Nedlands, Western Australia 6009
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    Linz, Upper Austria 4021
    Austria

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    Vienna, 1090
    Austria

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    Wien, 1140
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    Alken, 3570
    Belgium

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    Brussel, 1020
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    Leuven, 3000
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    Brampton, Ontario L6Y 0P6
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    Quebec, G1S 4L8
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    Hradec Kralove, CZE 500 05
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    Brno Bohunice, Czech Republic 625 00
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    Zlin, Czech Republic 762 75
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    Lynchburg, Virginia 24502
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    Madison, Wisconsin 53705-3611
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