A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Kodiak Sciences Inc
Study ID
NCT04964089
Phase
PHASE3
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • KSI-301 — DRUG
    Intravitreal Injection
  • Aflibercept — DRUG
    Intravitreal Injection
  • Sham Procedure — OTHER
    The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Study Details

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Key Dates

Start date
Jun 23, 2021
Status verified
Jun 2024
Primary completion
Mar 28, 2023
Completion
Apr 6, 2023

Study Design

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

Arms

  • Experimental: KSI-301 (Treatment Group A)
    Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
  • Active Comparator: Aflibercept (Treatment Group B)
    Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.

Primary Outcome Measure

Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. [ Time Frame: Day 1 to Week 48 ]

Locations (65)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LLCPhoenixArizona85014-
Northwest Arkansas Retina AssociatesSpringdaleArkansas72762-
California Retina ConsultantsBakersfieldCalifornia93309-
Eye Medical Center of FresnoFresnoCalifornia93720-
Retina Consultants of Orange CountyFullertonCalifornia92835-
UCSD Jacobs Retina CenterLa JollaCalifornia92037-
Retina Associates of Orange CountyLaguna HillsCalifornia92653-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-
Retina Consultants of San DiegoPowayCalifornia92064-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92374-
Retinal Consultants Medical Group IncSacramentoCalifornia95819-
Orange County Retina Medical GroupSanta AnaCalifornia92705-
Colorado Retina Associates PCLakewoodColorado80228-
Retina Group of New EnglandWaterfordConnecticut06385-
Florida Eye Microsurgical InstituteBoynton BeachFlorida33426-
Rand Eye InstituteDeerfield BeachFlorida33064-
National Ophthalmic Research InstituteFort MyersFlorida33912-
Retina Health CenterFort MyersFlorida33907-
Florida Eye AssociatesMelbourneFlorida32901-
Retina Specialty InstitutePensacolaFlorida32503-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33703-
Retina Associates of FloridaTampaFlorida33609-
Southeast Retina CenterAugustaGeorgia30909-
University of ChicagoChicagoIllinois60637-
Springfield Clinic LLPSpringfieldIllinois62703-
Talley EyeEvansvilleIndiana47710-
Wolfe Eye ClinicWest Des MoinesIowa50266-
Retina Associates PALenexaKansas66215-
Retina Associates of KentuckyLexingtonKentucky40509-
Retina Group of WashingtonChevy ChaseMaryland20815-
Cumberland Valley Retina Consultants PCHagerstownMaryland21740-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
New England Retina ConsultantsSpringfieldMassachusetts01103-
Vitreo Retinal Associates PCWorcesterMassachusetts01603-
Foundation for Vision ResearchGrand RapidsMichigan49525-
Associated Retinal Consultants PCRoyal OakMichigan78073-
Vitreoretinal Surgery PAEdinaMinnesota55435-
Sierra Eye AssociatesRenoNevada89502-
The Retina Center of New JerseyBloomfieldNew Jersey07017-
NJ RetinaTeaneckNew Jersey07605-
Retina-Vitreous Surgeons of Central NYLiverpoolNew York13088-
Retina Associates of Western NYRochesterNew York14620-
Western Carolina Retinal Associate PAAshevilleNorth Carolina28803-
Cleveland Clinic Foundation, Cole Eye InstituteClevelandOhio44195-
Retina Associates of ClevelandClevelandOhio44130-
Retina NorthwestPortlandOregon97210-
Retina Consultants, LLCSalemOregon97302-
Cascade Medical Research InstituteSpringfieldOregon97477-
MidAtlantic RetinaPhiladelphiaPennsylvania19107-
Retina Research of BeaufortBeaufortSouth Carolina29902-
Charleston Neuroscience InstituteLadsonSouth Carolina29456-
Palmetto Retina CenterWest ColumbiaSouth Carolina296169-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Southeastern Retina Associates PCKnoxvilleTennessee37909-
Tennessee Retina PCNashvilleTennessee37203-
Retina Research Institute of TexasAbileneTexas79606-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasHoustonTexas77030-
Retina Consultants of Texas-(Katy)KatyTexas77494-
Texas Retina AssociatesPlanoTexas75075-
Austin Retina Associates (Round Rock)Round RockTexas78681-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retina Consultants of Texas - (Woodlands)The WoodlandsTexas77384-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-
Spokane EyeSpokaneWashington99204-

Find similar trials in Phoenix, AZ

By research site
Retinal Research Institute, LLC· Phoenix, AZNorthwest Arkansas Retina Associates· Springdale, ARCalifornia Retina Consultants· Bakersfield, CAEye Medical Center of Fresno· Fresno, CARetina Consultants of Orange County· Fullerton, CAUCSD Jacobs Retina Center· La Jolla, CA

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