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

Launched by EYEVENSYS · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medicine called PST-611 to see if it is safe and well-tolerated in people over 50 who have dry age-related macular degeneration (AMD), a common eye condition that affects vision as people get older. The study is in an early stage (Phase 1) and its main goal is to find out if taking a single dose of PST-611 causes any side effects or problems.

To join this trial, participants must be 50 years or older, have certain signs of dry AMD in one eye, and have a minimum level of vision in both eyes. People with recent eye infections, recent eye surgeries, or certain treatments for eye diseases won’t be eligible. If you take part, you will receive one dose of the study medicine and then be followed by the research team for about 16 weeks to check your eye health and overall safety. This study is not yet recruiting participants, but it offers a chance to help researchers learn more about a potential new treatment for dry AMD.

Gender

ALL

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 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.