A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03823300
Phase
PHASE3
Status
Completed

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

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

Interventions

  • Faricimab — DRUG
    Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
  • Aflibercept — DRUG
    Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
  • Sham Procedure — PROCEDURE
    The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.

Study Details

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Key Dates

Start date
Mar 11, 2019
Status verified
Jul 2025
Primary completion
Oct 5, 2020
Completion
Jan 7, 2022

Study Design

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

Arms

  • Experimental: Arm A: Faricimab
  • Active Comparator: Arm B: Aflibercept

Primary Outcome Measure

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 [ Time Frame: From Baseline through Week 48 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Arizona Retina and Vitreous ConsultantsPhoenixArizona85021-
Associated Retina ConsultantsPhoenixArizona85020-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-
Retinal Consultants Med GroupSacramentoCalifornia95825-
Orange County Retina Med GroupSanta AnaCalifornia92705-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Colorado Retina Associates, PCGoldenColorado80401-
Retina Group of FloridaFort LauderdaleFlorida33308-
Retina Care SpecialistsPalm Beach GardensFlorida33410-
Southern Vitreoretinal AssocTallahasseeFlorida32308-
Retina Associates of Florida, LLCTampaFlorida33609-
Southeast Retina CenterAugustaGeorgia30909-
Georgia Retina PCMariettaGeorgia30060-
Retina Consultants of Hawaii‘AieaHawaii96701-
University Retina and Macula Associates, PCOak ForestIllinois60452-
Prairie Retina CenterSpringfieldIllinois62704-
Raj K. Maturi, MD PCIndianapolisIndiana46290-
Wolfe Eye ClinicWest Des MoinesIowa50266-
Maine Eye CenterPortlandMaine04101-
The Retina Care CenterBaltimoreMaryland21209-
Cumberland Valley Retina PCHagerstownMaryland21740-
Retina SpecialistsTowsonMaryland21204-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
VitreoRetinal Surgery, PLLC.MinneapolisMinnesota55435-
Mid Atlantic Retina - Wills Eye HospitalCherry HillNew Jersey08034-
Island RetinaShirleyNew York11967-
Retina Assoc of Cleveland IncClevelandOhio44122-
The Ohio State University Havener Eye InstituteColumbusOhio43212-
Midwest RetinaDublinOhio43016-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Southeastern Retina Associates ChattanoogaChattanoogaTennessee37421-
Retina Res Institute of TexasAbileneTexas79606-
Austin Clinical Research LLCAustinTexas78750-
Austin Retina AssociatesAustinTexas78705-
Retina Center of TexasGrapevineTexas76051-
Retina Consultants of HoustonThe WoodlandsTexas77384-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-
Retina Associates of Utah, PLLCMurrayUtah84107-
Piedmont Eye CenterLynchburgVirginia24502-
Wagner Kapoor InstituteNorfolkVirginia23502-
Pacific Northwest RetinaSilverdaleWashington98383-

Find similar trials in Phoenix, AZ

By research site
Arizona Retina and Vitreous Consultants· Phoenix, AZAssociated Retina Consultants· Phoenix, AZNorthern California Retina Vitreous Associates· Mountain View, CARetinal Consultants Med Group· Sacramento, CAOrange County Retina Med Group· Santa Ana, CACalifornia Retina Consultants· Santa Barbara, CA

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