ClinicalTrials.gg
CompletedNCT07024732Updated Jul 13, 2026

A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration

A Phase 1 interventional study of PST-611 in Dry Age Related Macular Degeneration, sponsored by Eyevensys. Completed at 2 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Eyevensys · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 120 studies in Macular Degeneration with a site in France — 27 open to participants now, 34 under way, 8 of them phase 3. Macular Degeneration · France.

Enrollment
83rd of 84
8 · median 249
Started
2025
with 11 others
Phase 1
2 of 120
none open now
Registered
113th of 120
by date

Among the 120 studies in Macular Degeneration with a site in France, this one is the 83rd largest by enrollment of the 84 interventional ones, is one of 12 that started in 2025, is one of 2 in phase 1, and was the 113th registered.

By phase

120 studies; the count open now beside each. This study's row is marked.

Observational36 · 11 open
Phase 333 · 5 open
No phase27 · 5 open
Phase 214 · 5 open
Phase 46 · 0 open
Phase 1this study2 · 0 open
Phase 2/32 · 1 open

By the year they started

First in 2003; this study’s year is marked. 12 started in 2025.

Size and results

Median enrollment 249 across the 84 interventional studies, 219 across the 36 observational. Of the 79 that completed or were terminated, 35 (44%) have results posted.

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02

Study summary

The goal of this interventional study is to evaluate the safety and tolerability of single ascending doses of PST-611 in men and women over the age of 50 with dry age-related macular degeneration (AMD).

The main question it aims to answer is: Is PST-611-CT1 safe for participants?

Participants will:

  • Receive a single dose of PST-611
  • Will be followed up for a total of 16 weeks following PST-611 administration
Read the detailed description

The maximum study duration per patient is 28 Weeks (including an up to 12 week screening period + 16 weeks of follow-up after treatment).

The study is a single ascending dose study that investigates two PST-611 dose levels (low and high doses) in 2 successive dose groups. The study will enroll up to 12 participants.

03

Conditions studied

  • Dry Age Related Macular Degeneration

Keywords

  • Dry Age Related Macular Degeneration
  • PST-611
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • must give written , be able to make the required trial visits and follow instructions.
  • Female and male subjects 50 years of age or older.
  • Female subjects of 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 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

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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Active treatment

    This arm consists of 2 dose groups receiving a single ascending dose of PST-611. These groups will be dosed sequentially, low dose followed by high dose.

    Biological: PST-611

Interventions

  • BiologicalPST-611

    PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    Ocular and non-ocular adverse events frequency and severity

    Time frame: Screening to week 16

Secondary outcomes

  1. Intraocular pressure

    Intraocular pressure measured in mmHg

    Time frame: Screening to Week 16

  2. Best corrected visual acuity

    Best corrected visual acuity measured in ETDRS letters

    Time frame: Screening to Week 16

  3. Slit lamp biomicroscopy examination

    Abnormal examination results will be recorded

    Time frame: Screening to Week 16

  4. Dilated ophthalmoscopy examination

    Abnormal examination results will be recorded

    Time frame: Screening to Week 16

  5. Color fundus photography

    Abnormal findings will be recorded

    Time frame: Screening to Week 16

  6. Spectral Domain-Optical Coherence Tomography

    Abnormal findings will be recorded

    Time frame: Screening to Week 16

07

Study locations

2 sites
  • CHU de Grenoble-Hôpital Michallon
    Grenoble, France 38043, France
  • Hôpital Cochin
    Paris, 75014, France
08

References and documents

Publications

  • Bigot K, Gondouin P, Benard R, Montagne P, Youale J, Piazza M, Picard E, Bordet T, Behar-Cohen F. Transferrin Non-Viral Gene Therapy for Treatment of Retinal Degeneration. Pharmaceutics. 2020 Sep 1;12(9):836. doi: 10.3390/pharmaceutics12090836. PubMed 32882879 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Apr 2026, 9 months.

Of 60 industry-sponsored phase 1 interventional studies under Macular Degeneration, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 9 months is below that.

Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2025
First posted
Jun 17, 2025
StartActual
Jun 23, 2025
Primary completionActual
Apr 7, 2026
CompletionActual
Apr 7, 2026
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07024732
Lead sponsor
Eyevensys
Responsible party
Sponsor
First posted
Jun 17, 2025
Start date
Jun 23, 2025
Primary completion
Apr 7, 2026
Completion
Apr 7, 2026
Last update
Jul 13, 2026

Study contacts

Karine Bigot, PhD
study director · PulseSight Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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