Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 3:03 AM
Study NCT ID:
NCT01736592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration
Status:
ACTIVE_NOT_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:
Primary Objective:
To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.
Secondary Objective:
To assess:
* Safety
* Biological activity
To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.
Secondary Objective:
To assess:
* Safety
* Biological activity
Detailed Description:
Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444).
As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.
As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: