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Cell therapy trial aims to halt vision loss in dry AMD

NCT ID NCT05626114

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This study tests a cell therapy called OpRegen for people with geographic atrophy, an advanced form of dry age-related macular degeneration that causes blind spots. About 60 participants will receive a one-time injection of retinal cells under the retina during eye surgery. The main goals are to see if the delivery works safely and if it can improve or preserve vision.

What this could mean

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

Active substance
OpRegen (a retinal cell therapy)
What this could lead to
If successful, this could point toward a treatment that slows or stops vision loss from geographic atrophy.
What could go wrong
This is an early Phase IIa study with only 60 people, so results may not apply to everyone. The surgical delivery itself carries risks like infection or retinal damage.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Started

Mar 2023

Expected to finish

Mar 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 years and older

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: * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care * Diagnosis of GA secondary to AMD * Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) * Pseudophakic (study eye) Exclusion Criteria: * Pregnancy or breastfeeding * History of cognitive impairment or dementia * Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk Ocular Exclusion Criteria for Study Eye: * Any current or history of ocular disease other than GA that may confound assessment of the macula * History of retinal detachment * History of vitrectomy, glaucoma-filtering surgery, or corneal transplant * Uncontrolled glaucoma or advanced glaucoma * Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen * History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications * Any existing posterior segment device or implant Substudy: Inclusion Criteria: \- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol Exclusion Criteria: * Participants who meet any exclusion criteria listed in the parent study GR44251 * Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy

As listed by the trial registrant

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

Geographic atrophy

How to take part

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

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Austin Clinical Research, LLC

    RECRUITING

    Austin, Texas, 78750-2298, United States

  • Cincinnati Eye Institute

    RECRUITING

    Blue Ash, Ohio, 45242-5537, United States

  • Duke Eye Center

    RECRUITING

    Durham, North Carolina, 27705-4699, United States

  • Hadassah MC

    RECRUITING

    Jerusalem, 9112001, Israel

  • Mid Atlantic Retina

    RECRUITING

    Philadelphia, Pennsylvania, 19107-5109, United States

  • Piedmont Eye Center

    RECRUITING

    Lynchburg, Virginia, 24502-4271, United States

  • Retina Consultants of Texas

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    St. Petersburg, Florida, 33711-1141, United States

  • Retina-Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group

    RECRUITING

    Sacramento, California, 95825, United States

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502-1605, United States

  • Spokane Eye Clinical Research;Spokane Eye Surgery Center

    RECRUITING

    Spokane, Washington, 99204, United States

  • Tel Aviv Sourasky MC

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Tennessee Retina PC

    RECRUITING

    Nashville, Tennessee, 37203-1513, United States

  • The Retina Care Center

    RECRUITING

    Baltimore, Maryland, 21209-2219, United States

  • The Retina Institute

    RECRUITING

    St Louis, Missouri, 63128-1729, United States

  • West Coast Retina

    RECRUITING

    San Francisco, California, 94109-5520, United States

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