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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) - PINNACLE

Kodiak Sciences Inc · NCT06996080

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
300
US sites recruiting
48
Study start
July 16, 2025
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KSI-101; Sham Comparator

Conditions: Macular Edema Secondary to Inflammation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (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.
  • Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT 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.
  • Any history of or active occlusive retinal vasculitis in either eye.

Recruiting US locations

Study contacts (from the official record)

  • Kodiak Sciences Inc · (650) 281-0850 · ClinicalTrials@kodiak.com
A Phase 3 Study to Evaluate the Efficacy and Safety of… (NCT06996080) | Bored Studies