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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
About
Brief Summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
25-1418
Category
Eye/Ocular Disorders
Principal Investigator
Contact
- Jose Jesus Torres Salgado
Location
- UCLA Westwood