Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official 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) - PEAK

Keywords

Macular Edema Secondary to Inflammation, MESI, macular edema, inflammatory macular edema, macular edema associated with inflammation, KSI-101, KSI-101 5 mg, KSI-101 10 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD/Jacobs Retina Center accepting new patients
    La Jolla California 92093 United States
  • California Eye Specialists Medical Group, Inc. accepting new patients
    Redlands California 92373 United States
  • Retina Consultants of Southern California accepting new patients
    Redlands California 92374 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kodiak Sciences Inc
ID
NCT06990399
Phase
Phase 3 Macular Edema Research Study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated