A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participant
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
| Condition(s) | Macular Edema Secondary to Inflammation |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI) |
| Who can participate | 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 either eye. * Any history of or active occlusive retinal vasculitis in either eye. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Kodiak Sciences Inc |
| Locations | Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Bakersfield, California, United States; Glendale, California, United States; La Jolla, California, United States; Los Angeles, California, United States (+50 more sites) |
| Start date | 2025-07-16 |
| NCT ID | NCT06996080 |
| Official listing | https://clinicaltrials.gov/study/NCT06996080 |