Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Xbrane Biopharma AB
Study ID
NCT03805100
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Key Dates

First listed
Jan 15, 2019
Start date
Apr 19, 2019
Status verified
Feb 2023
Primary completion
May 11, 2021
Completion
Nov 11, 2021

Study Design

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

Arms

  • Experimental: Xlucane
    Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.
  • Active Comparator: Lucentis
    Lucentis (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.

Primary Outcome Measure

Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline and Week 8 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LLCGilbertArizona85296-
Arizona Retina and Vitreous ConsultantsPhoenixArizona85021-8880-
Retina Centers P.CTucsonArizona85704-5611-
Win RetinaArcadiaCalifornia91006-3607-
The Retina PartnersEncinoCalifornia91436-2018-
Mark B. Kislinger MD Inc.GlendoraCalifornia91741-
Retina Consultants Medical Group Inc.SacramentoCalifornia95819-
Colorado Retina AssociatesGoldenColorado80401-5069-
Fort Lauderdale Eye InstituteFort LauderdaleFlorida33324-3118-
Sarasota Retina InstituteSarasotaFlorida34239-7246-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-3919-
Southeast Retina CenterAugustaGeorgia30909-6440-
Georgia RetinaMariettaGeorgia30060-
Gailey Eye ClinicBloomingtonIllinois61704-
Sabates Eye CentersLeawoodKansas66211-
Retina Vitreous Surgeons of Central New York PCNew YorkNew York13224-
Retina Associates of Western New YorkRochesterNew York14620-4655-
Charleston Neuroscience InstituteLadsonSouth Carolina29456-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Retina Research Institute of TexasAbileneTexas79606-
Austin Retina AssociatesAustinTexas78705-1169-
Houston Eye AssociatesHoustonTexas77025-1756-
Retina Consultants of HoustonHoustonTexas77030-2727-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-1502-
Retina Consultants of HoustonThe WoodlandsTexas77384-
Strategic Clinical Research Group LLCWillow ParkTexas76087-

Find similar trials in Gilbert, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retinal Research Institute, LLC· Gilbert, AZArizona Retina and Vitreous Consultants· Phoenix, AZRetina Centers P.C· Tucson, AZWin Retina· Arcadia, CAThe Retina Partners· Encino, CAMark B. Kislinger MD Inc.· Glendora, CA

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