Phase 1 Study to Evaluate Safety and Tolerability of EO2002 Eye Injections With or Without Daily Ripasudil Drops for Corneal Edema

What this Trial Is About

Researchers are evaluating the safety and tolerability of multiple doses of EO2002, a treatment involving intracameral injections of magnetic human corneal endothelial cells, for people with corneal edema caused by endothelial dysfunction such as Fuchs dystrophy or pseudophakic bullous keratopathy. This open-label Phase 1 study is sponsored by the Asociacin para Evitar la Ceguera en Mxico and aims to understand how EO2002 works with or without the addition of topical Ripasudil drops. Participants receive EO2002 injections either with daily topical Ripasudil followed by a reinjection at week 6 and continued Ripasudil use, or EO2002 injections at Day 0 and Week 6 without Ripasudil. The study is non-randomized and involves close monitoring over a 32-week period to assess safety and tolerability of these treatments. Throughout the study, participants will undergo assessments of central corneal thickness and best corrected visual acuity to evaluate eye health and function. Safety will be carefully monitored during the 32 weeks of treatment. Participants should expect regular visits for injections, eye exams, and vision testing as part of their involvement in the study.

Study to Assess Safety and Tolerability of Multiple Doses of EO2002