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

NCT07290244 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-19

No results posted yet for this study

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

Conditions

  • Open Angle Glaucoma (OAG)
  • NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Interventions

GENETIC

ER-100 epigenetic therapy

ER-100 is an investigational AAV-based epigenetic therapy administered via intravitreal injection to one eye. It uses a modified adeno-associated virus (AAV) vector to deliver instructions for producing three transcription factors-OCT4, SOX2, and KLF4 (collectively referred to as OSK)-intended to reverse age-related epigenetic changes in retinal cells. Systemic doxycycline is administered for 8 weeks (56 days) to activate OSK expression. ER-100 does not alter the participant's existing genes, and the AAV vector has been engineered to eliminate its ability to cause infectious disease.

Sponsors & Collaborators

  • Life Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Rosenzweig-Lipson, PhD · Life Biosciences Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-05-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290244 on ClinicalTrials.gov