A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03622580
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
  • Faricimab — DRUG
    Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
  • Sham Procedure — PROCEDURE
    The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.

Study Details

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Key Dates

Start date
Sep 5, 2018
Status verified
Jul 2025
Primary completion
Oct 20, 2020
Completion
Sep 3, 2021

Study Design

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

Arms

  • Experimental: A: Faricimab 6 mg Q8W
    Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
  • Experimental: B: Faricimab 6 mg PTI
    Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections once every 4 weeks (Q4W), 8 weeks (Q8W), 12 weeks (Q12W), or 16 weeks (Q16W) up to Week 96, followed by the final study visit at Week 100.
  • Active Comparator: C: Aflibercept 2 mg Q8W
    Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.

Primary Outcome Measure

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations [ Time Frame: From Baseline through Week 56 ]

Locations (85)

FacilityCityStateZIPSite coordinators
Barnet Dulaney Perkins Eye CenterMesaArizona85206-
Arizona Retina and Vitreous ConsultantsPhoenixArizona85021-
Retina Associates Southwest PCTucsonArizona85704-
Retinal Diagnostic CenterCampbellCalifornia95008-
Eye Medical CenterFresnoCalifornia93720-
East Bay Retina ConsultantsOaklandCalifornia94609-
Southern CA Desert Retina ConsPalm DesertCalifornia92211-
California Eye Specialists Medical group Inc.PasadenaCalifornia91107-
Retina Consultants, San DiegoPowayCalifornia92064-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92373-
Kaiser Permanente Riverside Medical CenterRiversideCalifornia92505-
University of California, Davis, Eye CenterSacramentoCalifornia95817-
W Coast Retina Med Group IncSan FranciscoCalifornia94107-
Orange County Retina Med GroupSanta AnaCalifornia92705-
Colorado Retina Associates, PCLakewoodColorado80228-
Rand EyeDeerfield BeachFlorida33064-
Retina Care SpecialistsPalm Beach GardensFlorida33410-
Retina Specialty InstitutePensacolaFlorida32503-
Southern Vitreoretinal AssocTallahasseeFlorida32308-
Retina Associates of Florida, LLCTampaFlorida33609-
University of South FloridaTampaFlorida33612-
Georgia Retina PCMariettaGeorgia30060-
Retina Consultants of Hawaii‘AieaHawaii96701-
Midwest Eye InstituteIndianapolisIndiana46290-
Wolfe Eye ClinicWest Des MoinesIowa50266-
Retina AssociatesLenexaKansas66215-
Vitreo-Retinal ConsultantsWichitaKansas67214-
Retina Associates of KentuckyLexingtonKentucky40509-
Paducah Retinal CenterPaducahKentucky42001-
Maine Eye CenterPortlandMaine04101-
Johns Hopkins Med; Wilmer Eye InstBaltimoreMaryland21287-
The Retina Care CenterBaltimoreMaryland21209-
Retina Group of WashingtonChevy ChaseMaryland20815-
Cumberland Valley Retina PCHagerstownMaryland21740-
Beetham Eye Institute, Joslin Diabetes CenterBostonMassachusetts02215-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Vitreo-Retinal Associates, PCWorcesterMassachusetts01605-
Foundation for Vision ResearchGrand RapidsMichigan49546-
Assoc Retinal Consultants PCRoyal OakMichigan48073-
Associated Retinal Consultants, P.C.Traverse CityMichigan49686-
Vitreoretinal SurgeryEdinaMinnesota55435-
Midwest Vision Research FoundationChesterfieldMissouri63017-
Sierra Eye AssociatesRenoNevada89502-
Mid Atlantic Retina - Wills Eye HospitalCherry HillNew Jersey08034-
NJ RetinaEdisonNew Jersey08820-
Retinal & Ophthalmic Cons PCNorthfieldNew Jersey08225-
Retina Associates of NJTeaneckNew Jersey07666-
University of New MexicoAlbuquerqueNew Mexico87131-
Capital Region RetinaAlbanyNew York12206-
Long Is. Vitreoretinal ConsultGreat NeckNew York11021-
Retina Vit Surgeons/Central NYLiverpoolNew York13088-
MaculaCare, PLLCNew YorkNew York10021-
Island RetinaShirleyNew York11967-
Western Carolina Retinal Associate PAAshevilleNorth Carolina28803-
Char Eye Ear &Throat AssocCharlotteNorth Carolina28210-
Graystone EyeHickoryNorth Carolina28602-
Carolina Eye AssociatesSouthern PinesNorth Carolina28387-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cincinnati Eye InstituteCincinnatiOhio45242-
Retina Assoc of Cleveland IncClevelandOhio44122-
OSU Eye Physicians & SurgeonsColumbusOhio43212-
Midwest RetinaDublinOhio43016-
Retina Vitreous CenterEdmondOklahoma73013-
Retina NorthwestPortlandOregon97221-
Black Hills Eye InstituteRapid CitySouth Dakota57701-
Charles Retina InstituteMemphisTennessee38119-
Retina Res Institute of TexasAbileneTexas79606-
Austin Clinical Research LLCAustinTexas78750-
Retina Consultants of TexasBellaireTexas77401-
Texas Retina AssociatesDallasTexas75231-
Retina SpecialistsDeSotoTexas75115-
Valley Retina Institute P.A.HarlingenTexas78550-
Retina & Vitreous of TexasHoustonTexas77025-
Med Center Ophthalmology AssocSan AntonioTexas78240-
Eye Care Assoc of East TexasTylerTexas75701-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-
Retina Associates of UtahSalt Lake CityUtah84107-
University of Utah; Division of Gastroenterology/HepatologySalt Lake CityUtah84132-
University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1BurlingtonVermont05401-
Emerson Clinical Research InstituteFalls ChurchVirginia22042-
Piedmont Eye CenterLynchburgVirginia24502-
Wagner Macula & Retina CenterNorfolkVirginia23502-
Spokane Eye Clinical ResearchSpokaneWashington99204-
West Virginia University Eye InstituteMorgantownWest Virginia26506-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Mesa, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Barnet Dulaney Perkins Eye Center· Mesa, AZArizona Retina and Vitreous Consultants· Phoenix, AZRetina Associates Southwest PC· Tucson, AZRetinal Diagnostic Center· Campbell, CAEye Medical Center· Fresno, CAEast Bay Retina Consultants· Oakland, CA

Related Studies