Not currently recruiting at University of California Health

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 study on Macular Edema

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
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) - PINNACLE

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

  • 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.

You CAN'T join if...

  • ME in the Study Eye secondary to diabetes, RVO, or wAMD
  • Active or suspected ocular or periocular infection in either eye

Locations

  • UCLA Stein Eye Institute not yet accepting patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Global Research Management, Inc. not yet accepting patients
    Glendale 5352423 California 5332921 91204 United States
  • California Eye Specialists Medical Group, Inc. accepting new patients
    Pasadena 5381396 California 5332921 91107 United States
  • Retinal Consultants Medical Group Inc accepting new patients
    Sacramento 5389489 California 5332921 95841 United States
  • Stanford Byers Eye Institute not yet accepting patients
    Palo Alto 5380748 California 5332921 94303 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Kodiak Sciences Inc
ID
NCT06996080
Phase
Phase 3 Macular Edema Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated