Dry Age Related Macular DegenerationPhase 1NCT07024732
A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration
A Phase 1 study testing PST-611 in people with Dry Age Related Macular Degeneration, run by Eyevensys at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age Related Macular Degeneration
- What is being tested?
- PST-611
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2025to 7 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble-Hôpital Michallon
Grenoble, France, 38043
Hôpital Cochin
Paris, 75014
About this study
Official title: An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration
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.
- Conditions
- Dry Age Related Macular Degeneration
- Being tested
- PST-611
- Keywords
- Dry Age Related Macular Degeneration, PST-611
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PST-611Biological
PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | 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. Receives: Biological: PST-611 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Ocular and non-ocular adverse events frequency and severity
Measured: Screening to week 16
Secondary outcomes (6)
Intraocular pressure
Intraocular pressure measured in mmHg
Measured: Screening to Week 16
Best corrected visual acuity
Best corrected visual acuity measured in ETDRS letters
Measured: Screening to Week 16
Slit lamp biomicroscopy examination
Abnormal examination results will be recorded
Measured: Screening to Week 16
Dilated ophthalmoscopy examination
Abnormal examination results will be recorded
Measured: Screening to Week 16
Color fundus photography
Abnormal findings will be recorded
Measured: Screening to Week 16
Spectral Domain-Optical Coherence Tomography
Abnormal findings will be recorded
Measured: Screening to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start23 Jun 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single ascending dose design with 2 sequential dose groups (low dose group followed by high dose group)
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyevensys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karine Bigot, PhD, Study director, PulseSight Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024732
- Sponsor's protocol ID
- PST-611-CT1
- Other IDs
- 2024-519025-37-00
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07024732
- Acronym / sponsor ID
- PST-611-CT1
- Conditions
- Dry Age Related Macular Degeneration
- Keywords
- Dry Age Related Macular Degeneration, PST-611
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EyevensysIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single ascending dose design with 2 sequential dose groups (low dose group followed by high dose group)
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Biological: PST-611This 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PST-611PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle | Biological | Active treatment |
Primary outcome
Safety and Tolerability
Time frame: Screening to week 16
Ocular and non-ocular adverse events frequency and severity
6 secondary outcomes
Intraocular pressure
Time frame: Screening to Week 16
Best corrected visual acuity
Time frame: Screening to Week 16
Slit lamp biomicroscopy examination
Time frame: Screening to Week 16
Dilated ophthalmoscopy examination
Time frame: Screening to Week 16
Color fundus photography
Time frame: Screening to Week 16
Spectral Domain-Optical Coherence Tomography
Time frame: Screening to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 32882879Bigot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Bigot, PhD study director
PulseSight Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PST-611 in people with Dry Age Related Macular Degeneration, run by Eyevensys at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Screening to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.