Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491914
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
A Single-Arm Study of Aflibercept 8 mg Dosed in Adult Participants With Neovascular Age-Related Macular Degeneration nAMD or Diabetic Macular Edema DME
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration nAMD or Diabetic Macular Edema DME
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ELARA
Brief Summary:
This study is researching an experimental drug called aflibercept 8 mg referred to as study drug The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor anti-VEGF medications
The aim of the study is to see how safe and effective aflibercept 8 mg injections are when given as frequently as every 4 weeks The study is also looking at what side effects may happen from taking the study drug
The aim of the study is to see how safe and effective aflibercept 8 mg injections are when given as frequently as every 4 weeks The study is also looking at what side effects may happen from taking the study drug
Detailed Description:
None
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