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A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK

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

Who can join

Ages 18 and older · All sexes

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 20/40 and 20/320 Snellen equivalent) in the Study Eye.
* Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Exclusion Criteria:

* Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.
* Active or suspected ocular or periocular infection in either eye.
* Any history of or active occlusive retinal vasculitis in either eye.

About the study

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)

What is being tested

• KSI-101 (drug)
• Sham Comparator (other)

Sponsor: Kodiak Sciences Inc · Participants: 600 · Started: Jul 30, 2025

Contact the study team

• Kodiak Sciences Inc · Phone: (650) 281-0850

Official record on ClinicalTrials.gov — NCT06990399

Locations in the U.S.

Conditions

• Macular Edema

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.