An Open-label Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Geographic Atrophy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorEyevensys
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PST-611
Biological/VaccinePST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Active treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 52Secondary outcomes
1
Intraocular pressure
Intraocular pressure measured in mmHg
Time frame
Screening to week 522
Best corrected visual acuity
Best corrected visual acuity measured in ETDRS letters
Time frame
Screening to week 523
Slit lamp biomicroscopy examination
Changes over time will be recorded
Time frame
Screening to week 524
Dilated ophthalmoscopy examination
Changes over time will be recorded
Time frame
Screening to week 52 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: