Diabetic Macular Edema Treated With Ozurdex (DMEO) (DMEO)

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

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Dexamethasone Implant; Drug: Anti-VEGF injection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1 (dexamethasone implant/anti-VEGF); Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.	Drug: Dexamethasone Implant; Patients will receive a single injection of a dexmethasone implant; Drug: Anti-VEGF injection; Patients will receive PRN injections of an anti-VEGF agent
EXPERIMENTAL: Group 2 (anti-VEGF/dexamethasone implant); Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.	Drug: Dexamethasone Implant; Patients will receive a single injection of a dexmethasone implant; Drug: Anti-VEGF injection; Patients will receive PRN injections of an anti-VEGF agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (ESTIMATE): September 26, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: DMEO-001