Diabetic Macular Edema Treated With Ozurdex (DMEO)

Diabetic Macular Edema Clinical Trial

— DMEO  

Official title:

Diabetic Macular Edema Treated With Ozurdex (DMEO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01951066
• Other study ID #: DMEO-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: December 15, 2015
• Start date: October 2013

Study information

• Verified date: December 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

to measure the pro-permeability factors VEGF, SDF-1, and angiopoietin-2 in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents

Description:

Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of OZURDEX over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

It is important to test the effect of OZURDEX in patients who have had a suboptimal response to VEGF antagonists to determine if OZURDEX provides more sustained benefit and to simultaneously assess its effect on aqueous levels of pro-permeability factors.

Our primary objective is to measure the pro-permeability factors VEGF, SDF-1, and angiopoietin-2 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 OZURDEX.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• • Signed informed consent and authorization of use and disclosure of protected health information

• Age more than or equal to 18 years

• Diagnosis of diabetic macular edema

• Intraretinal or subretinal fluid in the macula determined by Spectralis OCT

• Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision

• Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

Exclusion Criteria:

• • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye

• Intraocular surgery in the study eye within 3 months of study entry

• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry

• Previous use of an anti-VEGF drug within 1 month of study entry

• Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry

• Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.

• Inability to comply with study or follow up procedures

• History of glaucoma. (Patients who have undergone filtration surgery may be included)

• Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

• Aphakic eyes with rupture of the posterior lens capsule.

• Eyes with ACIOL and rupture of the posterior lens capsule.

• Patients with hypersensitivity to dexamethasone or to any other components of the product

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• OZURDEX
Patients will receive a single injection of OZURDEX

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in aqueous levels of VEGF, SDF-1, and angiopoietin-2	The primary outcome measure is the change from baseline in aqueous levels of VEGF, SDF-1, and angiopoietin-2 at 1, 2, 3, and 4 months after injection of OZURDEX.	1, 2, 3, and 4 months	No