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One-Shot gene therapy could replace monthly eye injections for wet AMD

NCT ID NCT06550011

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a single injection of ABI-110 gene therapy into the eye for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The goal is to see if it is safe and can reduce the need for frequent anti-VEGF injections by helping the eye produce its own medicine. About 18 adults aged 50 to 89 with wet AMD will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 18 people

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

Started

Aug 2024

Expected to finish

Jan 2031

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

50 to 89 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.

Key Inclusion Criteria: * General: 1. Must be willing and able to provide written, signed informed consent. 2. Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent Study eye: 3. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center 4. The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening. 5. BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters) 6. History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment 7. Response to anti-VEGF at trial entry Key Exclusion Criteria: * Study or Fellow Eye: 1. Prior gene therapy, either eye 2. Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye 3. History of retinal disease other than wAMD or PCV, study eye 4. Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye. 5. History of (or active) retinal detachment, study eye 6. Uncontrolled glaucoma (defined as IOP \> 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye 7. History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye 8. Any prior treatment with photodynamic therapy or laser photocoagulation, study eye 9. History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.

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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.

Contacts and locations

Locations

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78240, United States