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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Macular Edema Secondary to Inflammation

In brief

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

Key facts

Study ID

NCT06996080

Run by

Kodiak Sciences Inc

People needed

300

Starts

2025-07-16

Expected to finish

2027-08-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retina Consultants of Minnesota — Saint Louis Park, Minnesota, United States (enrolling)
• The Retina Institute — St Louis, Missouri, United States (enrolling)
• AZ Retina & Vitreous Consultants — Phoenix, Arizona, United States (enrolling)
• UCSD/Jacobs Retina Center — La Jolla, California, United States (enrolling)
• California Retina Consultants (Bakersfield) — Bakersfield, California, United States (enrolling)
• California Retina Consultants (Oxnard) — Oxnard, California, United States (enrolling)
• Global Research Management, Inc. — Glendale, California, United States (enrolling)
• Research Network Arizona — Scottsdale, Arizona, United States (enrolling)
• California Eye Specialists Medical Group, Inc. — Redlands, California, United States (enrolling)
• Retina Consultants of Southern California — Redlands, California, United States (enrolling)
• Retinal Consultants Medical Group Inc — Sacramento, California, United States (enrolling)
• UCLA Stein Eye Institute — Los Angeles, California, United States (enrolling)
• Rocky Mountain Uveitis — Denver, Colorado, United States (enrolling)
• Coastal Eye Surgeons — Greenwich, Connecticut, United States (enrolling)
• Retina Consultants, PC — Manchester, Connecticut, United States (enrolling)
• Retina Group of New England, PC — Waterford, Connecticut, United States (enrolling)
• California Eye Specialists Medical Group, Inc. — Pasadena, California, United States (enrolling)
• Retina Group of Florida (Ft. Lauderdale) — Fort Lauderdale, Florida, United States (enrolling)
• Retina Vitreous Associates of Florida (St. Petersburg) — St. Petersburg, Florida, United States (enrolling)
• Retina Associates, LTD — Elmhurst, Illinois, United States (enrolling)
• Associated Vitreoretinal and Uveitis Consultants LLC — Carmel, Indiana, United States (enrolling)
• Midwest Eye Institute — Carmel, Indiana, United States (enrolling)
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (enrolling)
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (enrolling)
• St. Mary's Eye Surgery Center (Metropolitan Eye Research and Surgery Institute) — Palisades Park, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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