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Clinical Trials in the USA / NCT06996080
Recruiting Phase 3

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

NCT06996080 · tracked via the Priya Life Science USA tracker
Sponsor
Kodiak Sciences Inc
Phase
Phase 3
Started
2025-07-16
Last updated
2026-05-18

Condition(s) studied

Macular Edema Secondary to Inflammation

Investigational drug(s) / intervention(s)

KSI-101Sham Comparator

KSI-101: Intravitreal injection

Sham Comparator: Sham injections

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥320 and \<400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between \~20/25 and 20/320 Snellen equivalent) in the Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye. Exclusion Criteria: * ME in the Study Eye secondary to diabetes, RVO, or wAMD. * Active or suspected ocular or periocular infection in either eye. * Any history of or active occlusive retinal vasculitis in either eye.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
AZ Retina & Vitreous Consultants Phoenix Arizona Recruiting
Research Network Arizona Scottsdale Arizona Recruiting
California Retina Consultants (Bakersfield) Bakersfield California Recruiting
Global Research Management, Inc. Glendale California Recruiting
UCSD/Jacobs Retina Center La Jolla California Recruiting
UCLA Stein Eye Institute Los Angeles California Recruiting
California Retina Consultants (Oxnard) Oxnard California Recruiting
Stanford Byers Eye Institute Palo Alto California Not Yet Recruiting
California Eye Specialists Medical Group, Inc. Pasadena California Recruiting
California Eye Specialists Medical Group, Inc. Redlands California Recruiting
Retina Consultants of Southern California Redlands California Recruiting
Retinal Consultants Medical Group Inc Sacramento California Recruiting
Retina Specialists of Colorado (RSC) Denver Colorado Withdrawn
Rocky Mountain Uveitis Denver Colorado Recruiting
Coastal Eye Surgeons Greenwich Connecticut Recruiting
Retina Consultants, PC Manchester Connecticut Recruiting
Retina Group of New England, PC Waterford Connecticut Recruiting
Florida Eye Clinic Altamonte Springs Florida Not Yet Recruiting
Retina Group of Florida (Ft. Lauderdale) Fort Lauderdale Florida Recruiting
Retina Vitreous Associates of Florida (St. Petersburg) St. Petersburg Florida Recruiting
Retina Associates, LTD Elmhurst Illinois Recruiting
Associated Vitreoretinal and Uveitis Consultants LLC Carmel Indiana Recruiting
Midwest Eye Institute Carmel Indiana Recruiting
Cumberland Valley Retina Consultants Hagerstown Maryland Recruiting
Ophthalmic Consultants of Boston Boston Massachusetts Recruiting
Retina Consultants of Minnesota Saint Louis Park Minnesota Recruiting
The Retina Institute St Louis Missouri Recruiting
St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute) Palisades Park New Jersey Recruiting
Eye Associates of New Mexico, Vision Research Center Albuquerque New Mexico Not Yet Recruiting
Retina Associates of New York, P.C. New York New York Recruiting
North Carolina Retina Associates (Cary) Cary North Carolina Recruiting
North Carolina Retina Associates (Wake Forest) Wake Forest North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Ohio State University Columbus Ohio Recruiting
Cascade Medical Research Institute Springfield Oregon Recruiting
Erie Retina Research Erie Pennsylvania Recruiting
Vision Research Solutions Philadelphia Pennsylvania Withdrawn
Charleston Neuroscience Institute, LLC (Charleston) Charleston South Carolina Recruiting
Palmetto Retina Center (West Columbia) West Columbia South Carolina Recruiting
Ophthalmology Ltd Sioux Falls South Dakota Recruiting

+ 16 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06996080 on ClinicalTrials.gov ↗ ← All trials in the USA