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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
EU CTIS ID: 2025-525008-12-00
What this study is testing
To evaluate safety and tolerability of multiple doses of PST-611
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 at OCT and attributed to AMD, as evaluated by the Investigator. cRORA is defined on OCT by (1) presence of a region of hypertransmission of at least 250 µm in diameter in any lateral dimension, and (2) presence of a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, and (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear (Sadda et al., 2018). All the above listed criteria are to be met for presence of cRORA.
- 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. The incapacity to fully perform exploratory assessments or optional exploratory assessments is not a reason for not selecting a subject when all other inclusion and exclusion criteria are met.
- Participants must be affiliated to social security insurance (if applicable, in accordance with local/applicable regulations).
- 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
You likely can't join if
- 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, the first PST-611 administration.
- SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the Screening and Trial Baseline (E1) Visits.
- 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 previously exposed to any gene therapy product other than the non- viral gene therapy PST-611.
See the full eligibility criteria
Who can 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 at OCT and attributed to AMD, as evaluated by the Investigator. cRORA is defined on OCT by (1) presence of a region of hypertransmission of at least 250 µm in diameter in any lateral dimension, and (2) presence of a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, and (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear (Sadda et al., 2018). All the above listed criteria are to be met for presence of cRORA.
- 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. The incapacity to fully perform exploratory assessments or optional exploratory assessments is not a reason for not selecting a subject when all other inclusion and exclusion criteria are met.
- Participants must be affiliated to social security insurance (if applicable, in accordance with local/applicable regulations).
- 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. If peripapillary atrophy is present, the GA lesion area must be separate from the peripapillary atrophy and not be expected to merge with the peripapillary atrophy during the trial.
- If both eyes are eligible, the SE will be selected by the Investigator based on the totality of the clinical evaluation, including, e.g., projected GA lesion area growth rate and ease of treatment administration procedure performance.
- Best-Corrected Visual Acuity (BCVA) must be ≤ 75 ETDRS letters (Snellen ≤ 20/32) in the SE
What rules you out
- 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, the first PST-611 administration.
- SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the Screening and Trial Baseline (E1) Visits.
- 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 previously exposed to any gene therapy product other than the non- viral gene therapy PST-611.
- Subject legally incapacitated or having limited legal capacity falling under articles L1121-6 and L1121-8 of French Health Code
- 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, the first PST-611 administration.
- Subjects who lack a sufficient command of French language to give a written informed consent in that language.
- SE: any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection in the 12 weeks (84 days) prior to Dose 1, the first PST-611 administration.
- 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, the first dose of PST-611, and lesion must be clinically inactive. A history of wet AMD in the SE is not an exclusion criterion.
- 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, the first PST-611 administration.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.