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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) - PEAK

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

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18 years and older
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Phase 3
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Overview

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:

  • MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
  • BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) 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

Study details
    Macular Edema Secondary to Inflammation

NCT06990399

Kodiak Sciences Inc

15 October 2025

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