Status:
RECRUITING
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
Lead Sponsor:
Kodiak Sciences Inc
Conditions:
Macular Edema Secondary to Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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)
Eligibility Criteria
Inclusion
- 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
- ME in the Study Eye secondary to diabetes, RVO, or wAMD
- Active or suspected ocular or periocular infection in either eye
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06996080
Start Date
July 16 2025
End Date
July 1 2027
Last Update
September 12 2025
Active Locations (33)
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1
Research Network Arizona
Scottsdale, Arizona, United States, 85255
2
Global Research Management, Inc.
Glendale, California, United States, 91204
3
UCLA Stein Eye Institute
Los Angeles, California, United States, 90095
4
Stanford Byers Eye Institute
Palo Alto, California, United States, 94303