RecruitingPhase 3NCT06996080
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
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) - PINNACLE
Sponsor
Kodiak Sciences Inc
Enrollment
150 participants
Start Date
Jul 16, 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 Criteria2
- Patients with MESI, with a 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 at Day 1;
- Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
Exclusion Criteria2
- 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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Interventions
DRUGKSI-101
Intravitreal injection
OTHERSham Comparator
Sham injections
Locations(33)
View Full Details on ClinicalTrials.gov
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NCT06996080