Gene therapy injection aims to treat dry AMD

NCT ID NCT07024732

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests the safety of a single injection of PST-611, a DNA-based therapy, in people aged 50 and older with dry age-related macular degeneration (AMD). The therapy is designed to make the eye produce a protein that may protect against vision loss. Participants receive one dose and are monitored for 16 weeks to check for side effects.

What this could mean

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

Active substance
PST-611 (a DNA-based therapy injected into the eye muscle)
What this could lead to
If safe and effective, this approach could offer a new way to treat dry age-related macular degeneration by helping the eye produce a protective protein.
What could go wrong
This is a very early, small trial (8 people) focused only on safety, not on whether the treatment works. Side effects or lack of benefit are possible.

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

8 people

The number who actually took part.

Started

Jun 2025

Finished

Apr 2026

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: * must give written informed consent, be able to make the required trial visits and follow instructions. * Female and male subjects 50 years of age or older. * Female subjects of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study. They must agree to practice at least one effective method of birth control following administration of study medication. * In the study eye (SE) : at least one of the following must be present at OCT and attributed to AMD, as evaluated by the Investigator: Incomplete RPE and Outer Retinal Atrophy (iRORA), or Complete RPE and Outer Retinal Atrophy (cRORA). * In SE: BCVA must be 23 ETDRS letters (approximate Snellen equivalent 20/320) or better. * In the fellow eye: BCVA must be 34 letters (approximate Snellen equivalent 20/200) or better. Exclusion Criteria: \- Both eyes: any active intraocular or periocular infection or inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis), or history of intraocular or periocular infection or inflammation in the 12 weeks (84 days) prior to the PST-611 administration. Study eye: Any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection within 12 weeks (84 days) prior to the PST-611 administration. * SE: Any anti-VEGF IVT treatment within 4 weeks (28 days) prior to PST-611 dosing OR subjects who have required and received regular monthly injections of anti-VEGF drugs in the months preceding the trial and would thus have a higher likelihood of requiring and anti-VEGF treatment within 28 days of the PST-611 administration. * SE: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period. * SE: subject with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous shunt implant) or who underwent eye surgery within 12 weeks (84 days) of the PST-611 administration. * SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the screening and baseline visits.

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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

  • CHU de Grenoble-Hôpital Michallon

    Grenoble, France, 38043, France

  • Hôpital Cochin

    Paris, 75014, France

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