Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-25 @ 2:18 AM
Study NCT ID:
NCT01571232
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2012-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Sponsor:
Retina Macula Institute
Organization:
Study Overview
Official Title:
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
Status:
COMPLETED
Status Verified Date:
2021-03
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 purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.
Detailed Description:
This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.
Study Oversight
Has Oversight DMC:
False
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?: