A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Part of paid clinical trials in Arcadia, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06491914
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications. The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Key Dates

Start date
Jul 24, 2024
Status verified
Oct 2025
Primary completion
Aug 26, 2025
Completion
Jan 7, 2027

Study Design

Enrollment
1,118 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept 8 mg
    Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Primary Outcome Measure

Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through week 24 ]

Locations (53)

FacilityCityStateZIPSite coordinators
Win Retina - ArcadiaArcadiaCalifornia91006-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina Specialists of Beverly HillsBeverly HillsCalifornia90212-
Salehi Retina Institute dba Retina Associates of Southern CaliforniaHuntington BeachCalifornia92647-
South Coast Retina CenterLong BeachCalifornia90807-
California Eye Specialists Medical Group, Inc.PasadenaCalifornia91107-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92374-
Vrmg IncSacramentoCalifornia95825-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Eye care Center of Northern Colorado doing business as Advanced Vision Research InstituteLongmontColorado80503-
Retina Group of New EnglandWaterfordConnecticut06385-
Advanced Research, LLCDeerfield BeachFlorida33064-
Florida Retina Institute - JacksonvilleJacksonvilleFlorida32216-
Florida Retina ConsultantsLakelandFlorida33805-
Florida Retina Institute - OrlandoOrlandoFlorida32806-
Retina Speciality Institute - Pensacola, FloridaPensacolaFlorida32503-
Eye Associates of PinellasPinellas ParkFlorida33782-
Retina Vitreous Associates of Florida Saint PetersburgSt. PetersburgFlorida33711-
Retina Vitreous Associates of FloridaTampaFlorida33617-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Georgia RetinaMariettaGeorgia30060-
Retina Consultants of Hawaii, Inc.‘AieaHawaii96701-
University Retina and Macula Associates PC - LemontLemontIllinois60439-
Illinois Retina AssociatesOak ParkIllinois60304-
Cumberland Valley Retina Consultants-OphthalmologyHagerstownMaryland21740-
Mid Atlantic Retina Specialists HagerstownHagerstownMaryland21740-
Opthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of MinnesotaEdinaMinnesota55435-
Deep Blue Retina Clinical Research PLLCSouthavenMississippi38671-
Vision Research Center Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Vitreoretinal Consultants of NY - WestburyWestburyNew York11590-
North Carolina Retina AssociatesWake ForestNorth Carolina27587-
Retina Associates of Cleveland - BeachwoodBeachwoodOhio44122-
Cincinnati Eye InstituteCincinnatiOhio45242-
Tulsa Retina ConsultantsTulsaOklahoma74114-
EyeHealth NorthwestPortlandOregon97225-
Mid Atlantic RetinaBethlehemPennsylvania18017-
Sewickley Eye GroupSewickleyPennsylvania15143-
Charleston Neuroscience Institute LLCLadsonSouth Carolina29456-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Tennessee Retina, PCNashvilleTennessee37203-
Retina Research Institute of TexasAbileneTexas79606-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasBeaumontTexas77707-
Retina Consultants of Texas - HoustonBellaireTexas77401-
Texas Retina Associates - DallasDallasTexas75231-
Southwest Retina ConsultantsEl PasoTexas79902-
Retina Consultants of TexasKatyTexas77494-
Austin Retina AssociatesRound RockTexas78681-
Retina Consultants of TexasSan AntonioTexas78240-
Retina Consultants of Texas Brown Retina InstituteSan AntonioTexas78251-
Retina Consultants TexasThe WoodlandsTexas77384-
Pacific Northwest RetinaBellevueWashington98004-

Find similar trials in Arcadia, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Win Retina - Arcadia· Arcadia, CACalifornia Retina Consultants· Bakersfield, CARetina Specialists of Beverly Hills· Beverly Hills, CASalehi Retina Institute dba Retina Associates of Southern California· Huntington Beach, CASouth Coast Retina Center· Long Beach, CACalifornia Eye Specialists Medical Group, Inc.· Pasadena, CA

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