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
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
Inclusion Criteria: * 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. Exclusion Criteria: * ME in the Study Eye secondary to diabetes, RVO, or wAMD. * Active or suspected ocular or periocular infection in…