drugset / Trial / NCT07290244

Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)

NCT07290244 ↗

Phase 1 Recruiting 18 enrolled Life Biosciences Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of a single dose of ER-100 in adults with optic nerve conditions, specifically Open Angle Glaucoma (OAG) and Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). The main questions it aims to answer are: * Is ER-100 safe when given as a single dose to people with OAG or NAION * What side effects may occur, if any, after taking ER-100? Participants will: * Receive a single dose of ER-100 * Undergo safety assessments including detailed eye examination and laboratory tests * Provide body fluid samples (tears, saliva, feces, urine) to help researchers understand how the drug is processed and cleared from the body * Complete questionnaires about their quality of life * Be followed for up to 5 years to monitor long-term health and vision outcomes

Timeline

Start
2026-03-02
Primary completion
2027-05
Completion
2032-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ER-100 Gene therapy (AAV / viral vector) 2e+11 vg Intravitreal
Subject ER-100 Gene therapy (AAV / viral vector) 6e+11 vg Intravitreal