Diabetic Macular Edema Treated With Ozurdex (DMEO)

Phase 2CompletedNCT01951066

Johns Hopkins University20 enrolled

Overview

To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Dexamethasone ImplantDRUG

Patients will receive a single injection of a dexmethasone implant

Anti-VEGF injectionDRUG

Patients will receive PRN injections of an anti-VEGF agent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Wilmer Eye Institute

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent

Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).

Time frame: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent

Data from ClinicalTrials.gov

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