Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03584165
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-07
First Post:
2018-06-29
Brief Title:
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa
Sponsor:
NightstaRx Ltd a Biogen Company
Organization:
Biogen
Study Overview
Official Title:
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Previously Treated With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 AAV2-REP1 and in Subjects With X-Linked Retinitis Pigmentosa Previously Treated With Adeno-Associated Viral Vector Encoding RPGR AAV8-RPGR in an Antecedent Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
SOLSTICE
Brief Summary:
The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia CHM who have been previously treated with BIIB111 and who have exited an antecedent study these treated participants will be compared with untreated control participants who have exited the STAR NCT03496012 study and BIIB112 in participants with X-linked retinitis pigmentosa XLRP who have been previously treated with BIIB112 and who have exited an antecedent study
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 |
|---|---|---|---|
| 2017-003104-42 | EUDRACT_NUMBER | None | None |