A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Kodiak Sciences Inc
Study ID
NCT06996080
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Macular Edema Secondary to Inflammation

Eligibility Criteria

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

Interventions

  • KSI-101 — DRUG
    Intravitreal injection
  • Sham Comparator — OTHER
    Sham injections

Study Details

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)

Key Dates

Start date
Jul 16, 2025
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: KSI-101 5 mg
    Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
  • Experimental: KSI-101 10 mg
    Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
  • Sham Comparator: Sham
    Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing

Primary Outcome Measure

Mean change in BCVA [ Time Frame: Week 24 ]

Central Contacts

Locations (55)

FacilityCityStateZIPSite coordinators
AZ Retina & Vitreous ConsultantsPhoenixArizona85016-
Research Network ArizonaScottsdaleArizona85255-
California Retina Consultants (Bakersfield)BakersfieldCalifornia93309-
Global Research Management, Inc.GlendaleCalifornia91204-
UCSD/Jacobs Retina CenterLa JollaCalifornia92093-
UCLA Stein Eye InstituteLos AngelesCalifornia90095-
California Retina Consultants (Oxnard)OxnardCalifornia93036-
Stanford Byers Eye InstitutePalo AltoCalifornia94303-
California Eye Specialists Medical Group, Inc.PasadenaCalifornia91107-
California Eye Specialists Medical Group, Inc.RedlandsCalifornia92373-
Retina Consultants of Southern CaliforniaRedlandsCalifornia92374-
Retinal Consultants Medical Group IncSacramentoCalifornia95841-
Retina Specialists of Colorado (RSC)DenverColorado80222-
Rocky Mountain UveitisDenverColorado80246-
Coastal Eye SurgeonsGreenwichConnecticut06830-
Retina Consultants, PCManchesterConnecticut06042-
Retina Group of New England, PCWaterfordConnecticut06385-
Florida Eye ClinicAltamonte SpringsFlorida32701-
Retina Group of Florida (Ft. Lauderdale)Fort LauderdaleFlorida33308-
Retina Vitreous Associates of Florida (St. Petersburg)St. PetersburgFlorida33711-
Retina Associates, LTDElmhurstIllinois60126-
Associated Vitreoretinal and Uveitis Consultants LLCCarmelIndiana46032-
Midwest Eye InstituteCarmelIndiana46032-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of MinnesotaSaint Louis ParkMinnesota55416-
The Retina InstituteSt LouisMissouri63128-
St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)Palisades ParkNew Jersey07650-
Eye Associates of New Mexico, Vision Research CenterAlbuquerqueNew Mexico87109-
Retina Associates of New York, P.C.New YorkNew York10075-
North Carolina Retina Associates (Cary)CaryNorth Carolina27511-
North Carolina Retina Associates (Wake Forest)Wake ForestNorth Carolina27587-
Cleveland ClinicClevelandOhio44195-
Ohio State UniversityColumbusOhio43212-
Cascade Medical Research InstituteSpringfieldOregon97477-
Erie Retina ResearchEriePennsylvania16507-
Vision Research SolutionsPhiladelphiaPennsylvania19141-
Charleston Neuroscience Institute, LLC (Charleston)CharlestonSouth Carolina29414-
Palmetto Retina Center (West Columbia)West ColumbiaSouth Carolina29169-
Ophthalmology LtdSioux FallsSouth Dakota57108-
Tennessee Retina PCNashvilleTennessee37203-
Vanderbilt Eye InstituteNashvilleTennessee37232-
Retina Research Institute of TexasAbileneTexas79606-
Austin Retina Associates, PLLC (Austin)AustinTexas78705-
UT AustinAustinTexas78712-
Retina Consultants of Texas (Bellaire)BellaireTexas77401-
Texas Retina CenterHoustonTexas77030-
Retina Consultants of Texas (Katy)KatyTexas77494-
Texas Retina Associates (Plano)PlanoTexas75075-
Austin Retina Associates, PLLC (Round Rock)Round RockTexas78681-
Retina Consultants of Texas (San Antonio)San AntonioTexas78240-
Retina Consultants of Texas (Woodlands)The WoodlandsTexas77384-
Pacific Northwest Retina (Bellevue)BellevueWashington98004-
Pacific Northwest Retina (Silverdale)SilverdaleWashington98383-
Eye Clinic of WisconsinWausauWisconsin54403-

Find similar trials in Phoenix, AZ

By research site
AZ Retina & Vitreous Consultants· Phoenix, AZResearch Network Arizona· Scottsdale, AZCalifornia Retina Consultants (Bakersfield)· Bakersfield, CAGlobal Research Management, Inc.· Glendale, CAUCSD/Jacobs Retina Center· La Jolla, CAUCLA Stein Eye Institute· Los Angeles, CA

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