Overview

This trial is active, not recruiting.

Condition diabetic macular edema
Treatment ozurdex
Phase phase 2
Sponsor Johns Hopkins University
Start date October 2013
End date February 2016
Trial size 20 participants
Trial identifier NCT01951066, DMEO-001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Other)
ozurdex dexamethasone intravitreal implant
Patients will receive a single injection of OZURDEX

Primary Outcomes

Measure
change from baseline in aqueous levels of VEGF, SDF-1, and angiopoietin-2
time frame: 1, 2, 3, and 4 months

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title Diabetic Macular Edema Treated With Ozurdex (DMEO)
Principal investigator Peter A Campochiaro, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.