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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-85
SponsorLife Biosciences Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of optic neuritis (inflammation of the optic nerve) or repeated episodes of eye inflammation (uveitis) not caused by injury or surgery.

Allergic reactions to tetracycline antibiotics or steroid medications.

Moderate to severe cataracts, macular problems, or corneal issues that could interfere with eye testing.

Unable to keep your eyes focused on a target during testing.

Trial design

Treatments tested in this trial

  • ER-100 epigenetic therapy

Treatment groups

18 Participants
are divided into 3 treatment groups

Sponsors and collaborators