RecruitingPhase 3NCT06990399
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 Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Sponsor
Kodiak Sciences Inc
Enrollment
600 participants
Start Date
Jul 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
- Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the 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 Criteria3
- Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.
- Active or suspected ocular or periocular infection in either eye.
- Any history of or active occlusive retinal vasculitis in either eye.
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Interventions
DRUGKSI-101
Intravitreal injection
OTHERSham Comparator
Sham injections
Locations(56)
View Full Details on ClinicalTrials.gov
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NCT06990399