Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527423
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2007-09-06
Brief Title:
Randomized Single-Masked Long-Term Safety and Tolerability Study of VEGF Trap-Eye in AMD
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Single-Masked Long-Term Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration
Detailed Description:
Randomized Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatmentLong term 3 years treatment is intended to measure safety and tolerability as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity BCVA
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