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Trial record 1 of 2 for:    talon | Neovascular Age-related Macular Degeneration
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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) (TALON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005352
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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 : January 31, 2022
Estimated Study Completion Date : October 4, 2022


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




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



Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005352


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 76 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04005352    
Other Study ID Numbers: CRTH258A2303
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AMD, nAMD, wet AMD, RTH258, brolucizumab, double blind
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Diseases
Retinal Degeneration
Wet Macular Degeneration
Eye Diseases
Eye Diseases, Hereditary