Viewing Study NCT01951066


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Study NCT ID: NCT01951066
Status: COMPLETED
Last Update Posted: 2016-09-29
First Post: 2013-09-20
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Diabetic Macular Edema Treated With Ozurdex (DMEO)
Sponsor: Johns Hopkins University
Organization:

Study Overview

Official Title: Diabetic Macular Edema Treated With Ozurdex (DMEO)
Status: COMPLETED
Status Verified Date: 2016-08
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: DMEO
Brief Summary: To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema
Detailed Description: Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

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?: