A Phase 3 Study Evaluating Safety and Effectiveness of Intravitreal KSI-101 for Macular Edema Caused by Inflammation

What this Trial Is About

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation MESI. The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

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