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Intravitreal KSI-101 for macular edema caused by inflammation (PINNACLE)

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) - PINNACLE

Phase 3 Interventional Kodiak Sciences Inc · NCT06996080

This trial will test whether injections of KSI-101 can reduce retinal swelling and improve vision in adults with macular edema from 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 IDNCT06996080 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized interventional study comparing intravitreal KSI-101 injections to a sham procedure in participants with macular edema secondary to non-infectious intraocular inflammation. Eligible participants must meet optical coherence tomography (OCT) and visual acuity thresholds and will be followed with OCT imaging and standardized visual acuity testing. The study will monitor both efficacy outcomes related to retinal thickness and vision and safety outcomes related to ocular and systemic adverse events. Results will compare changes in central subfield thickness and best-corrected visual acuity between the KSI-101 and sham groups over the study period.

Who should consider this trial

Good fit: Adults with macular edema secondary to non-infectious intraocular inflammation, central subfield thickness between ≥320 and <400 microns on SD-OCT, and best-corrected visual acuity of 25–78 ETDRS letters in the study eye are ideal candidates.

Not a fit: Patients whose macular edema is due to diabetes, retinal vein occlusion, or wet AMD, or those with active ocular/periocular infection, are unlikely to benefit from this study.

Why it matters

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

How similar studies have performed: Other intravitreal biologic therapies have shown benefit for various types of macular edema, but KSI-101 is a newer agent being tested specifically for inflammatory macular edema at Phase 3.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients with MESI, with a CST of ≥320 and \<400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between \~20/25 and 20/320 Snellen equivalent) in the Study Eye at Day 1;
* 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.