Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06990399 | A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK | PHASE3 | RECRUITING | 600 | — | — | Jul 30, 2025 | Nov 1, 2027 | May 18, 2026 | 56 | United States, Puerto Rico |
| NCT06996080 | A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE | PHASE3 | RECRUITING | 300 | — | — | Jul 16, 2025 | Aug 1, 2027 | May 18, 2026 | 56 | United States, Puerto Rico |
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
| Arm | Type | Description |
|---|---|---|
| KSI-101 5 mg | EXPERIMENTAL | Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| KSI-101 10 mg | EXPERIMENTAL | Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| Sham | SHAM_COMPARATOR | Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing |
| Name | Type | Description |
|---|---|---|
| KSI-101 | DRUG | Intravitreal injection |
| Sham Comparator | OTHER | Sham injections |
Inclusion Criteria: * Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/...