Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398080
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-17
Brief Title:
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration nAMD and Diabetic Macular Edema DME in a Real-World Setting
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
Real-World Patient Characteristics Treatment Patterns and Outcomes Among Patients With Neovascular Age-Related Macular Degeneration nAMD and Diabetic Macular Edema DME Treated With Aflibercept 8 mg in the United States
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SPECTRUM-US
Brief Summary:
The purpose of this research study is to observe the patients clinical care and how EYLEA HD is used as a treatment in real-world settings Patients are asked to join the study because they have either neovascular age-related macular degeneration nAMDwet age-related macular degeneration AMD or diabetic macular edema DME Patients cannot have used EYLEA HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA HD aflibercept 8 mg
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None