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NCT06990399RecruitingPhase 3

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

A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
600 (estimated)
First submitted
17 May 2025
Start date
Jul 2025
Primary completion date
Apr 2027
Lead sponsor
Kodiak Sciences Inc
NCT number
NCT06990399

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 600
  • From Jul 2025 to the primary completion date, Apr 2027
  • 56 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active or suspected ocular or periocular infection in either eye.
  • Any history of or active occlusive retinal vasculitis in either eye.

Other

  • Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.

Who the study is looking for

  • Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
  • Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
  • BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye.
  • Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Oftalmologico Metropolitano
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Retina Research Institute of Texas
Coordinator of this site? Confirm its status
AbileneUnited StatesRecruiting
Eye Associates of New Mexico Vision Research Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesNot yet recruiting
Florida Eye Clinic
Coordinator of this site? Confirm its status
Altamonte SpringsUnited StatesNot yet recruiting
Austin Retina Associates, PLLC (Austin)
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
UT-Austin
Coordinator of this site? Confirm its status
AustinUnited StatesNot yet recruiting
California Retina Consultants (Bakersfield)
Coordinator of this site? Confirm its status
BakersfieldUnited StatesRecruiting
Retina Consultants of Texas (Bellaire)
Coordinator of this site? Confirm its status
BellaireUnited StatesRecruiting
Pacific Northwest Retina (Bellevue)
Coordinator of this site? Confirm its status
BellevueUnited StatesRecruiting
Ophthalmic Consultants of Boston
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Associated Vitreoretinal and Uveitis Consultants LLC
Coordinator of this site? Confirm its status
CarmelUnited StatesRecruiting
Midwest Eye Institute
Coordinator of this site? Confirm its status
CarmelUnited StatesRecruiting
North Carolina Retina Associates (Cary)
Coordinator of this site? Confirm its status
CaryUnited StatesRecruiting
Charleston Neuroscience Institute LLC - Charleston
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CharlestonUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesNot yet recruiting
Ohio State University
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ColumbusUnited StatesRecruiting
Retina Specialists of Colorado (RSC)
Coordinator of this site? Confirm its status
DenverUnited StatesWithdrawn
Rocky Mountain Uveitis
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Retina Associates, Ltd.
Coordinator of this site? Confirm its status
ElmhurstUnited StatesRecruiting
Erie Retina Research
Coordinator of this site? Confirm its status
ErieUnited StatesRecruiting
Retina Group of Florida (Ft. Lauderdale)
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Fort LauderdaleUnited StatesRecruiting
Global Research Management, Inc
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GlendaleUnited StatesRecruiting
Coastal Eye Surgeons
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GreenwichUnited StatesRecruiting
Cumberland Valley Retina Consultants
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HagerstownUnited StatesRecruiting
Texas Retina Center
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HoustonUnited StatesRecruiting
Retina Consultants of Texas - Katy
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KatyUnited StatesRecruiting
UCSD/Jacobs Retina Center
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La JollaUnited StatesRecruiting
UCLA Stein Eye Institute
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Los AngelesUnited StatesRecruiting
Retina Consultants PC
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ManchesterUnited StatesRecruiting
Tennessee Retina, PC
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NashvilleUnited StatesRecruiting
Vanderbilt Eye Institute
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NashvilleUnited StatesRecruiting
Retina Associates of New York, P.C.
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New YorkUnited StatesRecruiting
California Retina Consultants (Oxnard)
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OxnardUnited StatesRecruiting
St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute)
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Palisades ParkUnited StatesRecruiting
Stanford Byers Eye Institute
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Palo AltoUnited StatesNot yet recruiting
California Eye Specialists Medical Group, Inc.
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PasadenaUnited StatesRecruiting
Vision Research Solutions
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PhiladelphiaUnited StatesWithdrawn
AZ Retina & Vitreous Consultants
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PhoenixUnited StatesRecruiting
Texas Retina Associates (Plano)
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PlanoUnited StatesRecruiting
Retina Consultants of Southern California
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RedlandsUnited StatesRecruiting
California Eye Specialists Medical Group, Inc.
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RedlandsUnited StatesRecruiting
Austin Retina Associates, PLLC (Round Rock)
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Round RockUnited StatesRecruiting
Retinal Consultants Medical Group, Inc.
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SacramentoUnited StatesRecruiting
Retina Consultants of Minnesota
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Saint Louis ParkUnited StatesRecruiting
Retina Consultants of Texas: San Antonio
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San AntonioUnited StatesRecruiting
Research Network Arizona
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ScottsdaleUnited StatesRecruiting
Pacific Northwest Retina (Silverdale)
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SilverdaleUnited StatesRecruiting
Ophthalmology Ltd.
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Sioux FallsUnited StatesRecruiting
Cascade Medical Research Institute
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SpringfieldUnited StatesRecruiting
The Retina Institute
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Retina Vitreous Associates of Florida (St. Petersburg)
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Retina Consultants of Texas (Woodlands)
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The WoodlandsUnited StatesRecruiting
North Carolina Retina Associates (Wake Forest)
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Wake ForestUnited StatesRecruiting
Retina Group of New England, PC
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WaterfordUnited StatesRecruiting
Eye Clinic of Wisconsin
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WausauUnited StatesRecruiting
Palmetto Retina Center (West Columbia)
Coordinator of this site? Confirm its status
West ColumbiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.