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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle
CHU de Grenoble-Hôpital Michallon
Grenoble, France, France
Hôpital Lariboisière
Paris, France, France
Hôpital Cochin
Paris, France, France
Frequency and severity of ocular and non-ocular adverse events (Safety and Tolerability)
Ocular and non-ocular adverse events over time will be recorded
Time frame: Screening to week 52
Intraocular pressure
Intraocular pressure measured in mmHg
Time frame: Screening to week 52
Best corrected visual acuity
Best corrected visual acuity measured in ETDRS letters
Time frame: Screening to week 52
Slit lamp biomicroscopy examination
Changes over time will be recorded
Time frame: Screening to week 52
Dilated ophthalmoscopy examination
Changes over time will be recorded
Time frame: Screening to week 52
Color fundus photography
Changes over time will be recorded
Time frame: Screening to week 52
Spectral Domain-Optical Coherence Tomography
Changes over time will be recorded
Time frame: Screening to week 52
Quantitative contrast sensitivity function
Changes over time will be recorded
Time frame: 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
Time frame: 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
Time frame: Screening to week 52
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