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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04005352
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brolucizumab 6 mg — BIOLOGICAL
    Intra-vitreal injection
  • Aflibercept 2 mg — BIOLOGICAL
    Intra-vitreal injection

Study Details

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.

Key Dates

Start date
Sep 25, 2019
Status verified
Oct 2024
Primary completion
Sep 9, 2022
Completion
Sep 9, 2022

Study Design

Enrollment
734 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brolucizumab 6 mg
    3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.
  • Active Comparator: Aflibercept 2 mg
    3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

Primary Outcome Measure

Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye [ Time Frame: Up to Week 32 ]

Locations (24)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85020-
Novartis Investigative SiteHuntington BeachCalifornia92647-
Novartis Investigative SiteLoma LindaCalifornia92354-
Novartis Investigative SiteRiversideCalifornia92505-
Novartis Investigative SiteSanta AnaCalifornia92705-
Novartis Investigative SiteFort LauderdaleFlorida33309-
Novartis Investigative SiteFort MyersFlorida33912-7125-
Novartis Investigative SiteOrlandoFlorida32789-
Novartis Investigative SitePinellas ParkFlorida33782-
Novartis Investigative SiteWinter HavenFlorida33880-
Novartis Investigative SiteSpringfieldIllinois62704-
Novartis Investigative SiteIndianapolisIndiana46280-
Novartis Investigative SiteWest Des MoinesIowa50266-
Novartis Investigative SiteMinneapolisMinnesota55435-
Novartis Investigative SiteHickoryNorth Carolina28602-
Novartis Investigative SitePortlandOregon97210-
Novartis Investigative SiteSpringfieldOregon97477-
Novartis Investigative SiteGermantownTennessee38138-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteBellaireTexas77401-
Novartis Investigative SiteFort WorthTexas76104-
Novartis Investigative SiteHoustonTexas77025-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78240-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Huntington Beach, CANovartis Investigative Site· Loma Linda, CANovartis Investigative Site· Riverside, CANovartis Investigative Site· Santa Ana, CANovartis Investigative Site· Fort Lauderdale, FL

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