Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01301443
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2011-02-21
Brief Title:
Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration AMD
Sponsor:
Oxford BioMedica
Organization:
Oxford BioMedica
Study Overview
Official Title:
A Phase I Dose Escalation Safety Study of Subretinally Injected RetinoStat a Lentiviral Vector Expressing Endostatin and Angiostatin in Patients With Advanced Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2017-04
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:
GEM
Brief Summary:
The purpose of this first in man study is to examine the safety of an experimental gene transfer agent RetinoStat designed to treat neovascular age-related macular degeneration
Detailed Description:
There are two parts to the study A dose-escalation phase looking at three doses of RetinoStat starting with the lowest dose three patients will be recruited at each dose level The escalation phase will be followed by a dose confirmation phase where the highest dose that is safe and well tolerated will be examined in 9 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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