Ignite Creation Date:
2024-05-06 @ 2:24 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02036424
Status:
COMPLETED
Last Update Posted:
2015-12-01
First Post:
2014-01-13
Brief Title:
Anti-Vascular Endothelial Growth Factor Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Sponsor:
Raj K Maturi MD
Organization:
Maturi Raj K MD PC
Study Overview
Official Title:
A 10 Month Single Masked Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2015-11
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:
To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone in subjects with persistent diabetic macular edema The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity andor optical coherence topography OCT compared to the use of anti-VEGF alone
Detailed Description:
Statistics throughout this study referred to the number of eyes rather than the number of subjects Subjects were allowed to have both eyes in the study provided that inclusionexclusion criteria were met Five subjects had both eyes in the study 45 subjects were actually enrolled resulting in 50 study eyes
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