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)

FacilityCityStateZIP
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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