4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON) (TALON)

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

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
Age-related Macular Degeneration Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Biological: Brolucizumab 6 mg Biological: Aflibercept 2 mg Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double 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 : September 25, 2019
Estimated Primary Completion Date : November 23, 2022
Estimated Study Completion Date : January 6, 2023
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 Name: 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 Name: EYLEA

Outcome Measures
Primary Outcome Measures :
  1. Average change in Best-corrected visual acuity [ Time Frame: At Weeks 28 and 32 ]
    Visual acuity test

  2. Distribution of the last interval with no disease activity [ Time Frame: Up to Week 32 ]
    Treatment interval distribution


Secondary Outcome Measures :
  1. Distribution of the last interval with no disease activity [ Time Frame: Up to Week 64 ]
    Treatment interval distribution

  2. Distribution of the maximal intervals with no disease activity [ Time Frame: Up to Week 64 ]
    Treatment interval distribution

  3. Proportion of patients with no disease activit [ Time Frame: At Weeks 14 and 16 ]
    Disease activity assessment

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

  5. Average change in Best-corrected visual acuity [ Time Frame: At Weeks 60 and 64 ]
    Visual acuity test

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

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

  8. Average change from baseline in Central Subfield Thickness [ Time Frame: At Weeks 28 and 32 ]
    Spectral Domain Optical Coherence Tomography

  9. Average change from baseline in Central Subfield Thickness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At Weeks 60 and 64 ]
    Spectral Domain Optical Coherence Tomography

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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 146 study locations