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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03823287
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 treatments 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
Feb 19, 2019
Status verified
Jul 2025
Primary completion
Oct 26, 2020
Completion
Jan 18, 2022

Study Design

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

Arms

  • Experimental: Faricimab
  • Active Comparator: 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 (52)

FacilityCityStateZIPSite coordinators
Barnet Dulaney Perkins Eye CenterPhoenixArizona85016-
Retinal Research Institute, LLCPhoenixArizona85014-
Retina Associates Southwest PCTucsonArizona85704-
Retinal Diagnostic CenterCampbellCalifornia95008-
The Retina PartnersEncinoCalifornia91436-
Jacobs Retina center at the Shiley eye Institute UCSDLa JollaCalifornia92093-
South Coast Retina CenterLong BeachCalifornia90807-
Southern CA Desert Retina ConsPalm DesertCalifornia92211-
California Eye Specialists Medical group Inc.PasadenaCalifornia91107-
Retina Consultants, San DiegoPowayCalifornia92064-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92373-
University of California, Davis, Eye CenterSacramentoCalifornia95817-
Retina Consultants of SouthernColorado SpringsColorado80909-
Retina Group of New EnglandNew LondonConnecticut06320-
Rand EyeDeerfield BeachFlorida33064-
Florida Eye AssociatesMelbourneFlorida32901-
Retina Specialty InstitutePensacolaFlorida32503-
Fort Lauderdale Eye InstitutePlantationFlorida33324-
Retina Vitreous Assoc of FLSt. PetersburgFlorida33711-
Northwestern Medical Group/Northwestern UniversityChicagoIllinois60611-
Retina AssociatesLenexaKansas66215-
Johns Hopkins MedBaltimoreMaryland21287-
Retina Group of WashingtonChevy ChaseMaryland20815-
Tufts Medical CenterBostonMassachusetts02111-
Associated Retinal ConsultantsGrand RapidsMichigan49546-
Midwest Vision Research FoundationChesterfieldMissouri63017-
Retina Associates of St. LouisFlorissantMissouri63031-
Sierra Eye AssociatesRenoNevada89502-
NJ RetinaEdisonNew Jersey08820-
Retina Associates of NJTeaneckNew Jersey07666-
Long Is. Vitreoretinal ConsultGreat NeckNew York11021-
Ophthalmic Cons of Long IslandOceansideNew York11572-
Retina Assoc of Western NYRochesterNew York14620-
The Retina ConsultantsSlingerlandsNew York12159-
Retina Vit Surgeons/Central NYSyracuseNew York13224-
Western Carolina Retinal Associate PAAshevilleNorth Carolina28803-
Char Eye Ear &Throat AssocCharlotteNorth Carolina28210-
Graystone EyeHickoryNorth Carolina28602-
Carolina Eye AssociatesSouthern PinesNorth Carolina28387-
Cincinnati Eye InstituteCincinnatiOhio45242-
Retina NorthwestPortlandOregon97221-
Mid Atlantic Retina - Wills Eye HospitalPhiladelphiaPennsylvania19107-
Charleston Neuroscience InstLadsonSouth Carolina29456-
Black Hills Eye InstituteRapid CitySouth Dakota57701-
Charles Retina InstituteGermantownTennessee38138-
Tennessee Retina PC.NashvilleTennessee37203-
Texas Retina AssociatesDallasTexas75231-
Retina & Vitreous of TexasHoustonTexas77025-
Retina Consultants of TexasHoustonTexas77030-
Valley Retina Institute P.A.McAllenTexas78503-
Rocky Mountain RetinaSalt Lake CityUtah84107-
Spokane Eye Clinical ResearchSpokaneWashington99204-

Find similar trials in Phoenix, AZ

By research site
Barnet Dulaney Perkins Eye Center· Phoenix, AZRetinal Research Institute, LLC· Phoenix, AZRetina Associates Southwest PC· Tucson, AZRetinal Diagnostic Center· Campbell, CAThe Retina Partners· Encino, CAJacobs Retina center at the Shiley eye Institute UCSD· La Jolla, CA

Related Studies