Study detail
RecruitingPhase 3
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
Kodiak Sciences Inc
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
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
Interventions
- DrugKSI-101
Intravitreal injection
- OtherSham Comparator
Sham injections
Locations (33)
- Research Network ArizonaScottsdale, Arizona
- Global Research Management, Inc.Glendale, California
- UCLA Stein Eye InstituteLos Angeles, California
- Stanford Byers Eye InstitutePalo Alto, California
- California Eye Specialists Medical Group, Inc.Pasadena, California
- California Eye Specialists Medical Group, Inc.Redlands, California