Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01014052
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2009-11-12
Brief Title:
SafetyProof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis LCA or Retinitis Pigmentosa RP Due to Retinal Pigment Epithelial 65 Protein RPE65 or LecithinRetinol Acyltransferase LRAT Mutations
Sponsor:
QLT Inc
Organization:
QLT Inc
Study Overview
Official Title:
Phase 1b Study to Evaluate QLT091001 in Subjects With Leber Congenital Amaurosis LCA or Retinitis Pigmentosa RP Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein RPE65 or LecithinRetinol Acyltransferase LRAT
Status:
COMPLETED
Status Verified Date:
2013-05
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 of oral QLT091001
to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations
to evaluate duration of visual function improvement if observed
to evaluate the safety of oral QLT091001
to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations
to evaluate duration of visual function improvement if observed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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?:
None