Geographic AtrophyPhase 2NCT07705568
An Open-label Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Geographic Atrophy
A Phase 2 study testing PST-611 in people with Geographic Atrophy and Age - Related Macular Degeneration (AMD), run by Eyevensys at 3 sites in France.
Trial summary
The goals of this interventional study are (1) to evaluate the safety and tolerability of multiple doses of PST-611 in men and women over the age of 65 with geographic atrophy secondary to age-related macular degeneration and (2) to assess efficacy of multiple doses of PST-611 by assessing retinal morphology and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geographic Atrophy, Age - Related Macular Degeneration (AMD)
- What is being tested?
- PST-611
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects must give written informed consent, be able to make the required trial visits and follow instructions.
- Female and male subjects must be 65 years of age or older.
- In the study eye (SE): cRORA must be present on OCT and attributed to AMD, as evaluated by the Investigator.
- Documented recent history (i.e., over 3 to 12 months prior to first PST-611 administration) of GA lesion area progression, with a yearly growth projection of ≥ 1.6 mm2, in the SE
- GA lesion area prior to the first PST-611 administration must be between 1.25 mm2 and 16 mm2, as assessed by OCT, in SE.
- BCVA must be < or = 75 ETDRS letters (Snellen < or = 20/32) in the SE.
- Fixation, either central or eccentric, of both eyes, must be compatible with the performance of the ocular imaging and functional assessments included in the trial, as evaluated by the Investigator.
- If both eyes are eligible, the SE will be selected by the Investigator based on the totality of the clinical evaluation.
Who cannot join
- Both eyes (OU): 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 Dose 1.
- SE: any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection in the 12 weeks (84 days) prior to Dose 1.
- SE: the documented need for more than 2 anti-VEGF IVT treatments per year as well as any anti-VEGF IVT treatment within 3 months prior to Dose 1, and lesion must be clinically inactive.
- 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 in the 12 weeks (84 days) prior to Dose 1.
- SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the Screening and Trial Baseline Visits.
Show all 13Show fewer
- SE: subject with intraocular hypotension (<6 mmHg) in the SE that in the opinion of the Investigator would interfere with the PST-611 administrations or the evaluation of its safety or efficacy.
- SE: subject with history of scleritis, scleral thinning, cicatrizing conjunctival diseases, severe ocular allergies, severe ocular surface disease, ocular scarring or intraocular hardware (e.g., retained implant device) that could interfere with the PST-611 administrations or the evaluation of its safety.
- SE: any other concurrent ocular surface or intra-ocular condition, including retinal disease other than AMD, which, in the opinion of the Investigator, may pose a safety risk for the PST-611 administrations or interfere with the evaluation of its safety.
- Subject has any condition, which in the opinion of the Investigator, could compromise the subject's safety or adherence to the trial protocol or follow-up.
- Known/suspected hypersensitivity to any standard of care topical or local analgesics/anesthetics or other standard of care treatments used in the preparation of PST-611 administration procedure.
- Treatment with investigational medicinal products in the 12 weeks (84 days) prior to Dose 1.
- Subject previously exposed to any gene therapy product other than the non-viral gene therapy PST-611.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CHU de Grenoble-Hôpital Michallon
Grenoble, France, 38043
Christophe Chiquet, Pr, +33 (0)4 76 76 55 66, cchiquet@chu-grenoble.fr
Hôpital Lariboisière
Paris, France, 75010
Elodie Bousquet, MD, +33 (0)1 49 95 64 88, elodie.bousquet@aphp.fr
Hôpital Cochin
Paris, France, 75014
Francine Behar-Cohen, Pr, +33 (0)1 58 41 22 20, francine.cohen@aphp.fr
About this study
Official title: An Open-label Multiple Dose Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
The goals of this interventional study are (1) to evaluate the safety and tolerability of multiple doses of PST-611 in men and women over the age of 65 with geographic atrophy secondary to age-related macular degeneration and (2) to assess efficacy of multiple doses of PST-611 by assessing retinal morphology and visual function changes over time.
Participants will:
- receive one dose every 20 weeks, for a total of 3 doses.
- will be followed up for a total of 52 weeks following the first PST-611 dose.
Read the detailed description
The maximum study duration per patient is 64 Weeks (including an up to 12 week screening/baseline period + 52 weeks of follow-up after the first dose). The study is a multiple dose study that investigates one PST-611 dose level for the 3 planned administrations. The study will enroll up to 24 participants.
- Being tested
- PST-611
- Keywords
- Geographic atrophy, Age related macular degeneration, PST-611
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
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 1 dose group receiving multiple dose of PST-611 (one PST-611 dose level for the 3 planned administrations). Receives: Biological: PST-611 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of ocular and non-ocular adverse events (Safety and Tolerability)
Ocular and non-ocular adverse events over time will be recorded
Measured: Screening to week 52
Secondary outcomes (9)
Intraocular pressure
Intraocular pressure measured in mmHg
Measured: Screening to week 52
Best corrected visual acuity
Best corrected visual acuity measured in ETDRS letters
Measured: Screening to week 52
Slit lamp biomicroscopy examination
Changes over time will be recorded
Measured: Screening to week 52
Dilated ophthalmoscopy examination
Changes over time will be recorded
Measured: Screening to week 52
Color fundus photography
Changes over time will be recorded
Measured: Screening to week 52
Spectral Domain-Optical Coherence Tomography
Changes over time will be recorded
Measured: Screening to week 52
Quantitative contrast sensitivity function
Changes over time will be recorded
Measured: screening to week 52
Area of retinal pigment epithelium (RPE) loss
Changes over time will be recorded. Area of RPE loss will be assessed by deep learning-based analysis of SD-OCT
Measured: screening to week 52
Area of photoreceptor degeneration (EZ layer loss)
Changes over time will be recorded. EZ layer loss will be assessed by deep learning-based analysis of SD-OCT
Measured: Screening to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
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 Geographic AtrophyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Parallel enrolment
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07705568
- Sponsor's protocol ID
- PST-611-CT2
- Other IDs
- 2025-525008-12-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multiple Dose Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07705568
- Acronym / sponsor ID
- PST-611-CT2
- Keywords
- Geographic atrophy, Age related macular degeneration, PST-611
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- EyevensysIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jul 2026 (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 goals of this interventional study are (1) to evaluate the safety and tolerability of multiple doses of PST-611 in men and women over the age of 65 with geographic atrophy secondary to age-related macular degeneration and (2) to assess efficacy of multiple doses of PST-611 by assessing retinal morphology and visual function changes over time.
Participants will:
- receive one dose every 20 weeks, for a total of 3 doses.
- will be followed up for a total of 52 weeks following the first PST-611 dose.
Detailed description
The maximum study duration per patient is 64 Weeks (including an up to 12 week screening/baseline period + 52 weeks of follow-up after the first dose). The study is a multiple dose study that investigates one PST-611 dose level for the 3 planned administrations. The study will enroll up to 24 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parallel enrolment
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Biological: PST-611This arm consists of 1 dose group receiving multiple dose of PST-611 (one PST-611 dose level for the 3 planned administrations). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Subjects must give written informed consent, be able to make the required trial visits and follow instructions.
- Female and male subjects must be 65 years of age or older.
- In the study eye (SE): cRORA must be present on OCT and attributed to AMD, as evaluated by the Investigator.
- Documented recent history (i.e., over 3 to 12 months prior to first PST-611 administration) of GA lesion area progression, with a yearly growth projection of ≥ 1.6 mm2, in the SE
- GA lesion area prior to the first PST-611 administration must be between 1.25 mm2 and 16 mm2, as assessed by OCT, in SE.
Key exclusion criteria (13 listed)
- Both eyes (OU): 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 Dose 1.
- SE: any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection in the 12 weeks (84 days) prior to Dose 1.
- SE: the documented need for more than 2 anti-VEGF IVT treatments per year as well as any anti-VEGF IVT treatment within 3 months prior to Dose 1, and lesion must be clinically inactive.
- 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 in the 12 weeks (84 days) prior to Dose 1.
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
Frequency and severity of ocular and non-ocular adverse events (Safety and Tolerability)
Time frame: Screening to week 52
Ocular and non-ocular adverse events over time will be recorded
9 secondary outcomes
Intraocular pressure
Time frame: Screening to week 52
Best corrected visual acuity
Time frame: Screening to week 52
Slit lamp biomicroscopy examination
Time frame: Screening to week 52
Dilated ophthalmoscopy examination
Time frame: Screening to week 52
Color fundus photography
Time frame: Screening to week 52
Spectral Domain-Optical Coherence Tomography
Time frame: Screening to week 52
Quantitative contrast sensitivity function
Time frame: screening to week 52
Area of retinal pigment epithelium (RPE) loss
Time frame: screening to week 52
Area of photoreceptor degeneration (EZ layer loss)
Time frame: Screening to week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: 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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Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
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RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
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RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
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.
Karine Bigot, PhD study director
PulseSight Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PST-611 in people with Geographic Atrophy and Age - Related Macular Degeneration (AMD), run by Eyevensys at 3 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 16 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Bigot, PhD (+33 (0)1 84 79 10 62, karine.bigot@pulsesight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of ocular and non-ocular adverse events (Safety and Tolerability) (time frame: Screening to week 52). 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 NCT07705568, 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 16 Jul 2026.