A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
← catalyst calendarNCT06996080 · readout ≤ 193 d
Sponsored by Kodiak Sciences Inc (industry) · KOD — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
300estimated
Sites
56
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-16 | actual | When the study began enrolling |
| Primary completion | Feb 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Macular Edema Secondary to Inflammation
Interventions
- Drug: KSI-101 — also filed as tabirafusp alfa
- Other: Sham Comparator
Primary outcome
what the primary-completion date above is the date OFMean change in BCVA
measured Week 24
Permalink · KOD's whole pipeline · Catalyst calendar · Every registered study · What changed