A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT04740671
Phase
PHASE3
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • HLX04-O — DRUG
    Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.
  • ranibizumab — DRUG
    Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Study Details

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

Key Dates

First listed
Feb 5, 2021
Start date
Jul 1, 2021
Status verified
Jan 2025
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: HLX04-O
    Biologic recombinant anti-VEGF humanized monoclonal antibody
  • Active Comparator: Ranibizumab
    Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Primary Outcome Measure

Mean change from baseline in BCVA at at Week 36 [ Time Frame: up to at Week 36 ]

Locations (42)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants-GilbertGilbertArizona85297-
Associated Retina Consultants-PhoenixPhoenixArizona85020-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Global Research ManagementGlendaleCalifornia91204-
Atlantis Eyecare, VMR InstituteHuntington BeachCalifornia92647-
VMR InstituteHuntington BeachCalifornia92647-
South Coast Retina CenterLong BeachCalifornia90807-
Retina Consultants of Orange CountyLos AlamitosCalifornia90720-
MACRO Trials/ Lazar RetinaLos AngelesCalifornia90048-
East West Eye InstituteTorranceCalifornia90505-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Florida Retina Institute-OrlandoJacksonvilleFlorida32216-
Florida Retina Institute-OrlandoOrlandoFlorida32806-
University of South FloridaTampaFlorida33612-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Southeast Retina CenterAugustaGeorgia30909-
The University of ChicagoChicagoIllinois60637-
The University of Chicago, ILChicagoIllinois60637-
Illinois Retina AssociatesOak ParkIllinois60304-
Retina Associates LLCLenexaKansas66215-
Butchertown Clinical TrialsLouisvilleKentucky40206-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Retina Consultants of MinnesotaEdinaMinnesota55435-
VitreoRetinal Surgery PLLC DBA Retina Consultants of MinnesotaSaint Louis ParkMinnesota55416-
Mississippi Retina AssociatesJacksonMississippi39202-
Piedmont Retina SpecialistsAshevilleNorth Carolina27103-
Western Carolina Retinal AssociatesAshevilleNorth Carolina28803-
Graystone EyeHickoryNorth Carolina28602-
North Carolina Retina AssociatesWake ForestNorth Carolina27332-
Verum Research, LLCEugeneOregon97401-
Retina Consultants of Charleston - BeaufortBeaufortSouth Carolina29902-
Retina Consultants of Charleston: Charleston Neuroscience InstituteCharlestonSouth Carolina29414-
Carolina Center for SightFlorenceSouth Carolina29501-
Retina Consultants of NashvilleNashvilleTennessee37203-
Retina Consultants of TEXAS- NewcastleBellaireTexas77401-
Mt. Olympus Research-GarciaHoustonTexas77015-
Mt. Olympus Research/Museum Eye DistrictHoustonTexas77015-
Retina Consultants of TEXAS - Round RockRound RockTexas78681-
Retina Consultants of TexasThe WoodlandsTexas77384-
Retina Associates of Utah, PLLCSalt Lake CityUtah84107-
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107-
Emerson Clinical Research InstituteFalls ChurchVirginia22042-

Find similar trials in Gilbert, AZ

By research site
Associated Retina Consultants-Gilbert· Gilbert, AZAssociated Retina Consultants-Phoenix· Phoenix, AZRetina Consultants of Orange County· Fullerton, CAGlobal Research Management· Glendale, CAAtlantis Eyecare, VMR Institute· Huntington Beach, CAVMR Institute· Huntington Beach, CA

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