Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03984110
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2019-06-11
Brief Title:
One Year Trial Evaluating Safety of Ozurdex With Eylea
Sponsor:
Texas Retina Associates
Organization:
Texas Retina Associates
Study Overview
Official Title:
The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema A Prospective Comparative Trial
Status:
COMPLETED
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:
COED
Brief Summary:
One Year Trial Evaluating Safety of Ozurdex With Eylea COED
Detailed Description:
In this study the investigators aim to compare the effects of combined use of intravitreal injections of Ozurdex every three3 months and monthly Eyleaaflibercept to monthly intravitreal injections of aflibercept alone as measured by improvement in central subfield thickness from baseline at Week 48 in eyes with center-involving Diabetic Macular Edema and best-corrected visual acuity of 2040 or worse
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?:
True
Is an FDA AA801 Violation?:
None