Gene therapy injection aims to treat dry AMD
NCT ID NCT07024732
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
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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 Hide 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- AI eye scanner could catch retina disease earlier
- Bionic implant shows promise for restoring sight in dry AMD