Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03386474
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Brolucizumab 6 mg — DRUG
    Administered as opthalmic solution for an intravitreal injection to the study eye
  • Aflibercept 2 mg — DRUG
    Administered as an opthalmic solution for intravitreal injection to the study eye

Study Details

The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).

Key Dates

Start date
Jan 15, 2018
Status verified
Mar 2020
Primary completion
Sep 6, 2018
Completion
Sep 6, 2018

Study Design

Enrollment
151 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brolucizumab
    Brolucizumab 6 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8, and Week 16 or Week 20
  • Other: Aflibercept
    Aflibercept 2 mg solution for IVT injection, single injection at Day 1 (baseline), Week 8 and Week 16 to maintain the masking of the extension trial only.

Primary Outcome Measure

Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events [ Time Frame: Up to Week 24 ]

Locations (63)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePeoriaArizona85381-
Novartis Investigative SitePhoenixArizona85014-
Novartis Investigative SiteArcadiaCalifornia91006-
Novartis Investigative SiteHuntington BeachCalifornia92647-
Novartis Investigative SiteLa JollaCalifornia92093-
Novartis Investigative SiteLoma LindaCalifornia92354-
Novartis Investigative SiteMountain ViewCalifornia94040-
Novartis Investigative SiteOaklandCalifornia94609-
Novartis Investigative SiteRedlandsCalifornia92374-
Novartis Investigative SiteSacramentoCalifornia95841-
Novartis Investigative SiteColorado SpringsColorado80909-
Novartis Investigative SiteGoldenColorado80401-
Novartis Investigative SiteBridgeportConnecticut06606-
Novartis Investigative SiteNew LondonConnecticut06320-
Novartis Investigative SiteAltamonte SpringsFlorida32701-
Novartis Investigative SiteDeerfield BeachFlorida33064-
Novartis Investigative SiteFort MyersFlorida33912-7125-
Novartis Investigative SiteOcalaFlorida34474-
Novartis Investigative SitePalm Beach GardensFlorida33410-
Novartis Investigative SitePensacolaFlorida32503-
Novartis Investigative SiteSarasotaFlorida34239-
Novartis Investigative SiteTallahasseeFlorida32308-
Novartis Investigative SiteVero BeachFlorida32960-
Novartis Investigative SiteWinter HavenFlorida33880-
Novartis Investigative SiteBoiseIdaho83713-
Novartis Investigative SiteBloomingtonIllinois61704-
Novartis Investigative SiteIndianapolisIndiana46280-
Novartis Investigative SiteLeawoodKansas66211-
Novartis Investigative SiteShawnee MissionKansas66204-
Novartis Investigative SitePortlandMaine04102-
Novartis Investigative SiteBaltimoreMaryland21237-4350-
Novartis Investigative SiteWaldorfMaryland20602-
Novartis Investigative SiteLas VegasNevada89144-
Novartis Investigative SiteRenoNevada89502-
Novartis Investigative SiteToms RiverNew Jersey08755-
Novartis Investigative SiteAlbuquerqueNew Mexico87102-
Novartis Investigative SiteRochesterNew York14620-
Novartis Investigative SiteRochesterNew York14642-
Novartis Investigative SiteShirleyNew York11967-
Novartis Investigative SiteSyracuseNew York13224-
Novartis Investigative SiteCharlotteNorth Carolina28210-
Novartis Investigative SiteSouthern PinesNorth Carolina28387-
Novartis Investigative SiteClevelandOhio44122-
Novartis Investigative SiteClevelandOhio44195-
Novartis Investigative SiteDublinOhio43016-
Novartis Investigative SiteFairfieldOhio45014-
Novartis Investigative SiteCamp HillPennsylvania17011-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteAbileneTexas79606-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteFort WorthTexas76104-
Novartis Investigative SiteHoustonTexas77025-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SitePlanoTexas75093-
Novartis Investigative SiteSan AntonioTexas78215-
Novartis Investigative SiteSan AntonioTexas78240-
Novartis Investigative SiteRichmondVirginia23235-
Novartis Investigative SiteWarrentonVirginia20186-
Novartis Investigative SiteSilverdaleWashington98383-
Novartis Investigative SiteSpokaneWashington99204-
Novartis Investigative SiteUniversity PlaceWashington98467-
Novartis Investigative SiteMorgantownWest Virginia26506-
Novartis Investigative SiteMilwaukeeWisconsin53226-

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Novartis Investigative Site· Peoria, AZNovartis Investigative Site· Phoenix, AZNovartis Investigative Site· Arcadia, CANovartis Investigative Site· Huntington Beach, CANovartis Investigative Site· La Jolla, CANovartis Investigative Site· Loma Linda, CA

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