A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
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.
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.
Parallel
KSI-101
DrugIntravitreal injection
Sham Comparator
Other interventionSham injections
Mean change in BCVA
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
Proportion of participants with BCVA improvement
The proportion of participants in whom BCVA had improved by ≥15 letters from baseline to 24 weeks.
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