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

RecruitingPhase 3

Sponsor: Kodiak Sciences Inc

Conditions: Macular Edema Secondary to Inflammation

Interventions: KSI-101, Sham Comparator

Countries: United States, Puerto Rico

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (56)
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Bakersfield, California, United States
  • Glendale, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Oxnard, California, United States
  • Palo Alto, California, United States
  • Pasadena, California, United States
  • Redlands, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • Greenwich, Connecticut, United States
  • Manchester, Connecticut, United States
  • Waterford, Connecticut, United States
  • Altamonte Springs, Florida, United States
  • Fort Lauderdale, Florida, United States
  • St. Petersburg, Florida, United States
  • Elmhurst, Illinois, United States
  • Carmel, Indiana, United States
  • Carmel, Indiana, United States
  • Hagerstown, Maryland, United States
  • Boston, Massachusetts, United States
  • Saint Louis Park, Minnesota, United States
  • St Louis, Missouri, United States
  • Palisades Park, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • + 26 more on CT.gov