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

Korábbi kezelés

• 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: 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.
• 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.

Más betegség

• 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.
• 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.

Egyéb

• 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.

• 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.