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NCT Number: NCT06996080

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

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

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Key information

Conditions

Macular Edema Secondary to Inflammation Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Oftalmologico Metropolitano, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KSI-101

Drug

Intravitreal injection

Other names: tabirafusp alfa

Sham Comparator

Other

Sham injections

Primary outcomes

  1. Mean change in BCVA

    Time frame: Week 24

    Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.

Secondary outcomes

  1. Proportion of participants with BCVA improvement

    Time frame: Baseline to 24 weeks

    The proportion of participants in whom BCVA had improved by ≥15 letters from baseline to 24 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Kodiak Sciences Inc

CONTACT

[email protected]

(650) 281-0850

Sponsors and collaborators

Lead sponsor

Kodiak Sciences Inc

Industry

Registry information

Official study title

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

Acronym: PINNACLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 30, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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