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Intravitreal KSI-101 for macular edema due to inflammation (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

Phase 3 Interventional Kodiak Sciences Inc · NCT06990399

This trial will test whether injections of KSI-101 can reduce retinal swelling and improve vision in adults with macular edema caused by non-infectious inflammation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorKodiak Sciences Inc Industry-sponsored
Locations33 sites (Scottsdale, Arizona and 32 other locations)
Trial IDNCT06990399 on ClinicalTrials.gov

What this trial studies

This Phase 3 study gives intravitreal injections of KSI-101 or a sham procedure to participants with macular edema secondary to non-infectious intraocular inflammation. Participants must have a central subfield thickness of ≥400 µm on SD-OCT and best-corrected visual acuity between 25 and 70 ETDRS letters (about 20/40 to 20/320) in the study eye. The protocol compares changes in retinal thickness and visual acuity while closely monitoring ocular safety and signs of inflammation over the treatment period. The trial is being conducted at multiple U.S. eye centers, including sites in Arizona and California such as the UCLA Stein Eye Institute.

Who should consider this trial

Good fit: Adults with non-infectious intraocular inflammation and macular edema with CST ≥400 µm and BCVA between 25 and 70 ETDRS letters in the study eye are ideal candidates.

Not a fit: Patients whose macular edema is caused by diabetes, retinal vein occlusion, or wet AMD, or those with active ocular or periocular infection, are not expected to benefit from this study treatment.

Why it matters

Potential benefit: If successful, KSI-101 could reduce retinal swelling and improve or stabilize vision for people with inflammatory macular edema.

How similar studies have performed: Intravitreal biologic injections have helped other types of macular edema, but KSI-101 is a newer agent now being tested in Phase 3 for inflammatory macular edema.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in 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:

* ME in the Study Eye secondary to diabetes, RVO, or wAMD
* Active or suspected ocular or periocular infection in either eye

Where this trial is running

Scottsdale, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Macular Edema Secondary to InflammationMESImacular edemainflammatory macular edemamacular edema associated with inflammation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.