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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKodiak Sciences Inc

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • KSI-101
  • Sham Comparator

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators