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

Launched by KODIAK SCIENCES INC · May 17, 2025

Keywords

ClinConnect Summary

This clinical trial, called the PEAK study, is looking at a new treatment called KSI-101 for people who have macular edema caused by inflammation in the eye. Macular edema is a condition where fluid builds up in the part of the eye responsible for sharp vision, which can lead to vision problems. The trial will evaluate how well KSI-101 works and how safe it is for participants.

To be eligible for this study, participants should be between 65 and 74 years old and have specific eye conditions that can be measured using advanced eye imaging. They must have a certain level of vision as measured by a standard eye chart test and should be diagnosed with inflammation in the eye. However, people with macular edema caused by diabetes, certain eye diseases, or infections in the eye will not be able to participate. Those who join the study can expect to receive the KSI-101 treatment and will be closely monitored to see how their eyes respond. This study is not yet recruiting participants, so there will be more information available soon for those who are interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in 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.
• Exclusion Criteria:
• • ME in the Study Eye secondary to diabetes, RVO, or wAMD
• • Active or suspected ocular or periocular infection in either eye