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

Launched by KODIAK SCIENCES INC · May 21, 2025

Keywords

ClinConnect Summary

The PINNACLE trial is a clinical study designed to test a new treatment called KSI-101 for people who have macular edema caused by inflammation in their eyes. Macular edema is a condition where fluid builds up in the eye, leading to vision problems. This Phase 3 study aims to see how effective and safe KSI-101 is for treating this condition. The trial is currently not recruiting participants, but it will include adults aged 65 to 74 who have a specific level of vision and eye measurements.

To be eligible for this study, participants must have macular edema related to non-infectious inflammation and must meet certain vision criteria. Unfortunately, individuals with macular edema due to diabetes, retinal vein occlusion, or wet age-related macular degeneration, as well as those with eye infections, cannot participate. If you join the trial, you can expect to receive treatment and be closely monitored by healthcare professionals to assess how well the treatment works and if there are any side effects. This trial is an important step in finding better ways to help people with this eye condition.

Gender

ALL

Eligibility criteria

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