Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548568
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Real-world Study to Assess Safety of OZURDEX Dexamethasone Intravitreal Implant in Adult Participants With Diabetic Macular Edema in China
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Two-year Non-interventional Real-world Observational Study to Assess Safety of OZURDEX Dexamethasone Intravitreal Implant in Patients With Diabetic Macular Edema in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 dexamethasone intravitreal implant OZURDEX delivers dexamethasone gradually to the retina over time It is an approved drug for the treatment of diabetic macular edema DME This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China
Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice
Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications
No additional burden for participants in this trial is expected
Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice
Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications
No additional burden for participants in this trial is expected
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