NCT07024732

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

An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Eyevensys · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dry Age Related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	PST-611	PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

2 sites across 1 country: France