Trial Profile

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

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 07 Nov 2025

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At a glance

05 Nov 2025 According to Kodiak Sciences media release, phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling at a faster-than-expected pace, evaluating the top two dose levels (5 mg and 10 mg) in patients with MESI.
10 Sep 2025 Planned primary completion date changed from 1 Dec 2026 to 1 Feb 2026.
10 Sep 2025 Status changed from not yet recruiting to recruiting.

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