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

a study on Macular Edema

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
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
  • UCLA Stein Eye Institute accepting new patients
    Los Angeles California 90095 United States
  • Global Research Management, Inc. accepting new patients
    Glendale California 91204 United States
  • California Eye Specialists Medical Group, Inc. accepting new patients
    Pasadena California 91107 United States
  • Retinal Consultants Medical Group Inc accepting new patients
    Sacramento California 95841 United States
  • Stanford Byers Eye Institute not yet accepting patients
    Palo Alto California 94303 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
Contact us about this trial