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Can a gene therapy reverse aging in the eye? new trial begins

NCT ID NCT07290244

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a single dose of ER-100, a gene therapy designed to reverse age-related changes in retinal cells, in 18 adults with open-angle glaucoma or NAION. Participants receive the therapy via an eye injection and take doxycycline for 8 weeks to activate it. The main goal is to check safety and side effects, not yet to measure vision improvement. Researchers will follow participants for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ER-100 (a gene therapy that delivers instructions to produce OCT4, SOX2, and KLF4 proteins, activated by doxycycline)
What this could lead to
If safe, this could pave the way for a treatment that reverses age-related damage in optic nerve cells, potentially slowing vision loss in glaucoma and NAION.
What could go wrong
This is a very early Phase 1 trial with only 18 participants, so safety and effectiveness are not yet known. The therapy involves a virus-based gene therapy and requires 8 weeks of doxycycline, which may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Had cataract surgery or other eye surgery (including laser procedures) within 3 months before receiving the study drug. * Had cancer (except for basal cell skin cancer) within the past 5 years. * Have Type 1 diabetes, or poorly controlled Type 2 diabetes (A1c greater than 7 despite treatment). * Have memory or thinking problems that prevent you from understanding the study or completing the required tests. * Pregnant or breastfeeding. * Have a weakened immune system, including a history of organ transplant, or test positive for HIV, hepatitis B or C, or tuberculosis. * Have any other condition that, in the opinion of the study doctor, could increase your risk from the study drug or procedures, affect the study results, or make it hard for you to complete the study. * Have macular disease, advanced diabetic eye disease, or other eye conditions that limit vision in the study eye. * Eye pressure at screening is 30 mmHg or higher. * Taking certain medications (warfarin, dilantin, carbamazepine, or barbiturates) within 14 days before starting the study or during the first 8 weeks. * Have any other eye or vision problem that, in the opinion of the study doctor, could affect safety or interfere with vision testing. * Have previously received any gene therapy using adeno-associated virus (AAV). Additional Exclusion Criteria for Participants with Open-Angle Glaucoma (OAG): \- Diagnosed with glaucoma before age 40. Additional Exclusion Criteria for Participants with NAION: * Show signs of giant cell arteritis (a type of blood vessel inflammation), based on abnormal blood tests. * Had NAION start in both eyes at the same time.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Charleston Neuroscience Institute

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Columbia University Irving Medical Center/Edward S. Harkness Eye Institute

    RECRUITING

    New York, New York, 10032, United States

  • Global Research Management, Inc.

    RECRUITING

    Glendale, California, 91204, United States

  • Mass Eye and Ear

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

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