Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03496012
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2018-03-07
Brief Title:
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomised Open Label Outcomes-Assessor Masked Prospective Parallel Controlled Group Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector AAV2 Encoding Rab Escort Protein 1 REP1
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia CHM
Detailed Description:
This study was previously posted by NightstaRx Ltd In October 2020 sponsorship of the trial was transferred to Biogen
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 |
|---|---|---|---|
| 2015-003958-41 | EUDRACT_NUMBER | NightstaRx Ltd a Biogen Company | None |