Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978622
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-07-31
Brief Title:
Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Multi-country Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant DEX-I
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:
None
Brief Summary:
The dexamethasone 700 μg intravitreal implant DEX-I delivers dexamethasone gradually to the retina over time It is an approved drug for the treatment of DME This study will assess adult participants with diabetic macular edema DME and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting
Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally
Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers Only one eye per participant will be evaluated in the study
No additional burden for participants in this trial is expected
Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally
Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers Only one eye per participant will be evaluated in the study
No additional burden for participants in this trial is expected
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?:
False
Is an FDA AA801 Violation?:
None