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
Condition(s) studied
Macular Edema Secondary to Inflammation
Investigational drug(s) / intervention(s)
KSI-101 →Sham 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
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)
- Mean change in BCVA — Week 24
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
Trial sites (56)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Kodiak Sciences Inc trials in the USA
Other trials for the same condition
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