An Open-label Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Geographic Atrophy

ClinicalTrials.gov ID

NCT07705568

Lead Sponsor

EyevensysINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

24Estimated

Last Update Posted

Jul 16, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2028Estimated

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

Brief 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 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.

• Geographic Atrophy
• Age - Related Macular Degeneration (AMD)

• PST-611

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

EyevensysINDUSTRY

elodie.bousquet@aphp.fr+33 (0)1 49 95 64 88

francine.cohen@aphp.fr+33 (0)1 58 41 22 20

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

  NCT07024732

  CompletedInterventionalPhase 1Updated Jul 13, 2026
• A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

  NCT03178149

  RecruitingInterventionalPhase 1Updated Sep 3, 2026
• A Study in Adults With Geographic Atrophy

  NCT07606365

  Not yet recruitingInterventionalPhase 2Updated May 28, 2026
• Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

  NCT01342926

  CompletedInterventionalPhase 2Updated May 5, 2017
• A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

  NCT07215234

  RecruitingInterventionalPhase 1Phase 2Updated Jul 1, 2026
• Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

  NCT05893537

  TerminatedInterventionalPhase 2Updated Apr 16, 2025