Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Ocular Therapeutix, Inc.
Study ID
NCT06495918
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • OTX-TKI — DRUG
    Intravitreal Injection of OTX-TKI
  • Aflibercept — DRUG
    Intravitreal Injection of 2mg of aflibercept
  • Aflibercept — DRUG
    Intravitreal Injection of 8mg of aflibercept

Study Details

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration

Key Dates

Start date
Nov 27, 2024
Status verified
Jun 2025
Primary completion
Jan 8, 2027
Completion
Jan 8, 2027

Study Design

Enrollment
825 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OTX-TKI Re-dose
  • Active Comparator: Aflibercept 2mg on label
  • Other: Aflibercept 8mg high dose

Primary Outcome Measure

Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 48 ]

Locations (84)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantGilbertArizona85297-
Associated Retina Consultants, Ltd.PhoenixArizona85020-
Retinal Research Institute, LLCPhoenixArizona85053-
Retina Macula Institute of ArizonaScottsdaleArizona85255-
California Retina ConsultantsBakersfieldCalifornia93309-
The Retina PartnersEncinoCalifornia91436-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Atlantis EyecareHuntington BeachCalifornia92647-
Salehi Retina Institute, Inc., dba Retina Associates of Southern CaliforniaHuntington BeachCalifornia92647-
Kaiser Permanente Division of ResearchOaklandCalifornia94611-
California Retina ConsultantsOxnardCalifornia93036-
Stanford Health Care - Byers Eye InstitutePalo AltoCalifornia94303-
Stanford University School of Medicine, Byers Eye InstitutePalo AltoCalifornia94303-
California Eye Specialists Medical Group, INCPasadenaCalifornia91107-
Retinal Consultants Medical GroupSacramentoCalifornia95841-
Orange County Retina Medical GroupSanta AnaCalifornia92705-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Macula Retina Vitreous Research InstituteTorranceCalifornia90503-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
RSC Research, LLCDenverColorado80210-
Colorado Retina AssociatesLakewoodColorado80228-
Retina Consultants, P.CManchesterConnecticut06042-
Retina Group of New EnglandWaterfordConnecticut06385-
Advanced Research LLC.Deerfield BeachFlorida33064-
Rand Eye InstituteDeerfield BeachFlorida33064-
Retina Group of FloridaFort LauderdaleFlorida33308-
Florida Retina ConsultantsLakelandFlorida33805-
South Florida Retina InstituteMiamiFlorida33145-
Florida Retina InstitudeOrlandoFlorida32806-
Retina Specialty InstitutePensacolaFlorida32503-
MedEye AssociatesSouth MiamiFlorida33143-
Retina Vitreous Associates of Florida- Saint PetersburgSt. PetersburgFlorida33711-
Retina Vitreous Associates of FloridaTampaFlorida33617-
Southeast Retina CenterAugustaGeorgia30909-
University Retina and Macula Associates, PCOak ForestIllinois60452-
Illinois Retina AssociatesOak ParkIllinois60304-
Springfield Clinic Opthalmology DepartmentSpringfieldIllinois62703-
Associate Vitreoretinal and Uveitis ConsultantsCarmelIndiana46032-
Retina Partners Midwest, P.C.CarmelIndiana46290-
Retina Partners MidwestIndianapolisIndiana46290-
Wolfe Clinic PC dba Wolfe Eye ClinicWest Des MoinesIowa50026-
The Retina Group of Washington - Chevy ChaseChevy ChaseMaryland20815-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Mid Atlantic Retina SpecialistsHagerstownMaryland21740-
Retina Specialists - Towson OfficeTowsonMaryland21204-
Associated Retinal Consultants, P.C.Royal OakMichigan48073-
Retina Consultants of MinnesotaMinneapolisMinnesota55435-
Mississippi Retina AssociatesMadisonMississippi39110-
The Retina InstituteSt LouisMissouri63128-
Sierra Eye AssociatesRenoNevada89502-
Envision Ocular, LLCBloomfieldNew Jersey07003-
Vision Research Center Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Retina Vitreous Surgeons of CNY, PCLiverpoolNew York13088-
Asheville Eye Associates (AEA) - AshevilleAshevilleNorth Carolina28803-
Cincinnati Eye InstituteCincinnatiOhio45242-
EyeHealth NorthwestPortlandOregon97225-
Erie Retina ResearchEriePennsylvania16507-
Palmetto Retina Center, LLCAikenSouth Carolina29802-
Charleston Neuroscience Instititute, LLCBeaufortSouth Carolina29902-
Palmetto Retina Center, LLCFlorenceSouth Carolina29501-
Palmetto Retina Center, LLCWest ColumbiaSouth Carolina29169-
Black Hills Regional Eye Institute, LLPRapid CitySouth Dakota57701-
Charles Retina InstituteGermantownTennessee38138-
Southeastern Retina Associates PCJohnson CityTennessee37604-
Tennessee Retina, PCNashvilleTennessee37203-
Retina Research Institute of TexasAbileneTexas79606-
Texas Retina AssociatesArlingtonTexas76012-
Austin Research Center for RetinaAustinTexas78705-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasBeaumontTexas77707-
Retina Consultants of TexasBellaireTexas77401-
Star Vision ResearchBurlesonTexas76028-
Texas Retina AssociatesDallasTexas75231-
Texas Retina CenterHoustonTexas77030-
Retina Consultants of TexasKatyTexas77494-
Retina Consultants of TexasSan AntonioTexas78240-
Retina Center of TexasSouthlakeTexas76092-
Retina Consultants of TexasThe WoodlandsTexas77384-
Retina Associates of UtahSalt Lake CityUtah84107-
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107-
Retina Group of WashingtonFairfaxVirginia22031-
Vistar Eye CenterRoanokeVirginia24019-
Eye Clinic of Wisconsin, SCWausauWisconsin54403-

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