Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03140969
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2017-05-01
Brief Title:
Study to Evaluate QR-110 in Lebers Congenital Amaurosis LCA Due to the c29911655AG Mutation pCys998X in the CEP290 Gene
Sponsor:
ProQR Therapeutics
Organization:
ProQR Therapeutics
Study Overview
Official Title:
An Open-label Multiple Dose Dose Escalation Study to Evaluate the Safety and Tolerability of QR-110 in Subjects With Lebers Congenital Amaurosis LCA Due to c29911655AG Mutation pCys998X in the CEP290 Gene
Status:
COMPLETED
Status Verified Date:
2024-10
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 purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 pCys998X mutation
Detailed Description:
The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 pCys998X mutation Subjects will receive QR-110 in one eye every 3 months for a maximum of 4 doses Up to 3 dose levels of QR-110 will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000813-22 | EUDRACT_NUMBER | None | None |