Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109499
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2005-04-28
Brief Title:
Study of AdGVPEDF11D in Neovascular Age-related Macular Degeneration AMD
Sponsor:
GenVec
Organization:
GenVec
Study Overview
Official Title:
An Open-label Phase I Single Administration Dose- Escalation Study of AdGVPEDF11D in Neovascular Age-related Macular Degeneration AMD
Status:
COMPLETED
Status Verified Date:
2011-05
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:
None
Brief Summary:
The primary purpose of this study is to assess the safety of AdGVPEDF11D when given to patients with wet age-related macular degeneration AMD AdGVPEDF11D is a replication deficient E1 E3 and E4 deleted adenovirus vector containing the gene for the PEDF pigment epithelium-derived factor protein PEDF is a protein that naturally exists in the human eye but whose levels are altered in diseases characterized by ocular neovascularization like AMD The PEDF protein is known to have anti-angiogenic effects or in other words it has the ability to inhibit growth of new blood vessels
AdGVPEDF11D will be delivered once via intravitreal injection into one eye The injected eye will be the eye with the worst visual acuity
AdGVPEDF11D will be delivered once via intravitreal injection into one eye The injected eye will be the eye with the worst visual acuity
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