A Phase 1 Single Dose Study to Evaluate the Safety and Tolerability of ER-100 in Optic Neuropathies [Open Angle Glaucoma (OAG) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)]
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
• Have clear eye structures and be able to have your pupils safely dilated so the doctor can examine the back of your eye.
• Able to understand the study and sign a consent form.
• Be between 40 and 85 years old.
• Willing and able to follow the study schedule, including all visits and tests, and speak a language for which the study materials are available.
• If a participant can become pregnant, must agree to use a condom and one highly effective form of birth control during sex for at least 4 months after receiving the study drug (ER-100).
⁃ For participants with open-angle glaucoma (OAG):
• Diagnosis of open-angle glaucoma in the study eye.
• Eye pressure must be less than 30 mmHg, measured with a standard test.
• Visual field test must show moderate to advanced vision loss (MD score between -6 and -20 dB).
• Not expected to need glaucoma surgery in the study eye within 2 months after receiving ER-100.
• Have reasonably good vision in the study eye (at least 20/80 on a standard eye chart).
⁃ For participants with NAION (non-arteritic anterior ischemic optic neuropathy):
• Had a sudden, painless loss of vision in one eye within 14 days before receiving ER-100, confirmed by a specialist. Having had NAION in the other eye is okay.
• The affected eye must show swelling of the optic nerve.
• Visual field test must show vision loss consistent with optic nerve damage (MD worse than -3.0 dB).
• If only one eye is affected, there must be a difference in pupil response between the two eyes.
• Have vision in the affected eye between 20/40 and 2/500 on a standard eye chart.