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

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ClinicalTrials.gov Identifier: NCT01951066
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : August 1, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Dexamethasone Implant Drug: Anti-VEGF injection Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Diabetic Macular Edema Treated With Ozurdex (DMEO)
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent [ Time Frame: 1, 2, 3, and 4 months after injection of 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951066


Locations
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United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
More Information
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Responsible Party: Peter A Campochiaro, MD, Professor of Ophthalmology and Neuroscience, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01951066    
Other Study ID Numbers: DMEO-001
First Posted: September 26, 2013    Key Record Dates
Results First Posted: August 1, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents