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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03622593
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 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
Oct 9, 2018
Status verified
Jul 2025
Primary completion
Oct 19, 2020
Completion
May 31, 2023

Study Design

Enrollment
951 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 up to once every 16 weeks (Q16W) through 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 (50)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020-
Retinal Research Institute, LLCPhoenixArizona85053-
Northwest Arkansas Retina AssociatesSpringdaleArkansas72764-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
The Retina PartnersEncinoCalifornia91436-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-
Retinal Consultants Med GroupSacramentoCalifornia95825-
California Retina ConsultantsSanta BarbaraCalifornia93103-
California Retina ConsultantsSanta MariaCalifornia93454-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
University of ColoradoAuroraColorado80045-
Retina Consultants of SouthernColorado SpringsColorado80909-
Retina Group of New EnglandWaterfordConnecticut06385-
Retina Group of FloridaFort LauderdaleFlorida33308-
National Ophthalmic Research InstituteFort MyersFlorida33912-
Florida Eye AssociatesMelbourneFlorida32901-
Bascom Palmer Eye InstitutePalm Beach GardensFlorida33418-
Fort Lauderdale Eye InstitutePlantationFlorida33324-
Retina Vitreous Assoc of FLSt. PetersburgFlorida33711-
Southeast Retina CenterAugustaGeorgia30909-
University Retina and Macula Associates, PCOak ForestIllinois60452-
Prairie Retina CenterSpringfieldIllinois62704-
Retina SpecialistsBaltimoreMaryland21204-
Tufts Medical CenterBostonMassachusetts02111-
Associated Retinal ConsultantsGrand RapidsMichigan49546-
Vitreo-Retinal AssociatesGrand RapidsMichigan49546-
Retina Consultants of NevadaLas VegasNevada89144-
Envision Ocular, LLCBloomfieldNew Jersey07003-
Long Is. Vitreoretinal ConsultHauppaugeNew York11788-
New York UniversityNew YorkNew York10017-
Ophthalmic Cons of Long IslandOceansideNew York11572-
Retina Assoc of Western NYRochesterNew York14620-
University of Rochester Flaum Eye InstituteRochesterNew York14642-
The Retina ConsultantsSlingerlandsNew York12159-
Cleveland Clinic FoundationClevelandOhio44195-
Mid Atlantic Retina - Wills Eye HospitalPhiladelphiaPennsylvania19107-
Retina Consultants Of CarolinaGreenvilleSouth Carolina29605-
Charleston Neuroscience InstLadsonSouth Carolina29456-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Southeastern Retina Associates ChattanoogaChattanoogaTennessee37421-
Southeastern Retina AssociatesKnoxvilleTennessee37922-
Tennessee Retina PCNashvilleTennessee37203-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasBellaireTexas77401-
Retina Center of TexasSouthlakeTexas76092-
Univ of Virginia OphthalmologyCharlottesvilleVirginia22903-
Retina Institute of VirginiaRichmondVirginia23235-
Pacific Northwest RetinaSilverdaleWashington98383-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Associated Retina Consultants· Phoenix, AZRetinal Research Institute, LLC· Phoenix, AZNorthwest Arkansas Retina Associates· Springdale, ARCalifornia Retina Consultants· Bakersfield, CARetina-Vitreous Associates Medical Group· Beverly Hills, CAThe Retina Partners· Encino, CA

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