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

Eyevensys

Status and phase: Begins enrollment this month; Phase 1

Conditions: Dry Age Related Macular Degeneration

Treatments: Biological: PST-611

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024732

2024-519025-37-00 (EU Trial (CTIS) Number)

PST-611-CT1

Details and patient eligibility

About

The goal of this interventional study is to evaluate the safety and tolerability of single ascending doses of PST-611 in men and women over the age of 50 with dry age-related macular degeneration (AMD).

The main question it aims to answer is: Is PST-611-CT1 safe for participants?

Participants will:

• Receive a single dose of PST-611
• Will be followed up for a total of 16 weeks following PST-611 administration

Full description

The maximum study duration per patient is 28 Weeks (including an up to 12 week screening period + 16 weeks of follow-up after treatment).

The study is a single ascending dose study that investigates two PST-611 dose levels (low and high doses) in 2 successive dose groups. The study will enroll up to 12 participants.

Enrollment: 12 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 50 years of age or older. Female subjects of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study. They must agree to practice at least one effective method of birth control following administration of study medication.

In the study eye, at least one of the following must be present at OCT and attributed to AMD, as evaluated by the Investigator: Incomplete RPE and Outer Retinal Atrophy (iRORA), or Complete RPE and Outer Retinal Atrophy (cRORA).

Best-Corrected Visual Acuity (BCVA), must be 23 ETDRS letters (approximate Snellen equivalent 20/320) or better in the study eye.

Subject's fellow eye BCVA must be 34 letters (approximate Snellen equivalent 20/200) or better.

Exclusion criteria

Both eyes: 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 the PST-611 administration.

Study eye: Any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection within 12 weeks (84 days) prior to the PST-611 administration.

Study eye: Any anti-VEGF IVT treatment within 4 weeks (28 days) prior to PST-611 dosing OR subjects who have required and received regular monthly injections of anti-VEGF drugs in the months preceding the trial and would thus have a higher likelihood of requiring and anti-VEGF treatment within 28 days of the PST-611 administration.

Study eye: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period.

Study eye: subject with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous shunt implant) or who underwent eye surgery within 12 weeks (84 days) of the PST-611 administration. Study eye: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the screening and baseline visits.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Active treatment

Experimental group

Description:

This arm consists of 2 dose groups receiving a single ascending dose of PST-611. These groups will be dosed sequentially, low dose followed by high dose.

Treatment:

Biological: PST-611