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NCT07705568
An Open-label Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Geographic Atrophy
Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 24
Sponsor: Eyevensys
Location: CHU de Grenoble-Hôpital Michallon Grenoble France
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.
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 (\
Source: ClinicalTrials.gov (NCT07705568). StuddyBuddy aggregates publicly available trial information.