Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT07024732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration
Sponsor:
Eyevensys
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-519025-37-00 | CTIS | None | View |