A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Kodiak Sciences Inc
Study ID
NCT04603937
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 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, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

Key Dates

Start date
Sep 30, 2020
Status verified
Aug 2024
Primary completion
Apr 27, 2023
Completion
Aug 31, 2023

Study Design

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

Arms

  • Experimental: KSI-301 (Arm A)
    Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100.
  • Active Comparator: Aflibercept (Arm B)
    Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100.

Primary Outcome Measure

Mean Change in BCVA [ Time Frame: Day 1 to Week 64 ]

Locations (40)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LLCPhoenixArizona85014-
Retina Vitreous AssociatesBeverly HillsCalifornia90211-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-
Retina Consultants of San DiegoPowayCalifornia92064-
Retinal Consultants Medical Group IncSacramentoCalifornia95825-
Retina Group of New EnglandWaterfordConnecticut06385-
Florida Eye Microsurgical InstituteBoynton BeachFlorida33426-
Rand Eye InstituteDeerfield BeachFlorida33064-
National Ophthalmic Research InstituteFort MyersFlorida33912-
Fort Lauderdale Eye InstitutePlantationFlorida33324-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33703-
Southern Vitreoretinal AssociatesTallahasseeFlorida32308-
Southeast Retina CenterAugustaGeorgia30909-
Georgia Retina, P.C.MariettaGeorgia30060-
Retina Consultants of Hawaii, Inc‘AieaHawaii96701-
Retina Specialists of IdahoBoiseIdaho83713-
Talley EyeEvansvilleIndiana47710-
Maine Eye CenterPortlandMaine04101-
Associated Retinal Consultants PCRoyal OakMichigan48073-
Vitreoretinal Surgery PAMinneapolisMinnesota55435-
Retina Consultants of NVHendersonNevada89052-
Sierra Eye AssociatesRenoNevada89502-
Vitreo Retinal ConsultantsHauppaugeNew York11788-
Retina-Vitreous Surgeons of Central NYLiverpoolNew York13088-
Ophthalmic Consultants of Long IslandOceansideNew York11572-
Retina Associates of Western NYRochesterNew York14620-
Asheville Eye AssociatesAshevilleNorth Carolina28803-
Cleveland Clinic Foundation, Cole Eye InstituteClevelandOhio44195-
Retina Consultants, LLCSalemOregon97302-
Southeastern Retina Associates PCKnoxvilleTennessee37922-
Retina Research Institute of TexasAbileneTexas79606-
Austin Research Center for RetinaAustinTexas78705-
Texas Retina AssociatesFort WorthTexas76108-
Retina Consultants of Houston-(Katy)KatyTexas77494-
Texas Retina AssociatesPlanoTexas75075-
Austin Retina Associates (Round Rock)Round RockTexas78681-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retina Consultants of Houston - (Woodlands)The WoodlandsTexas77384-
Retina Institute of VirginiaRichmondVirginia23235-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retinal Research Institute, LLC· Phoenix, AZRetina Vitreous Associates· Beverly Hills, CARetina Consultants of Orange County· Fullerton, CANorthern California Retina Vitreous Associates· Mountain View, CARetina Consultants of San Diego· Poway, CARetinal Consultants Medical Group Inc· Sacramento, CA

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