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An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02188173
First Posted: July 11, 2014
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).

Condition Intervention
Macular Edema Drug: dexamethasone 700 ㎍ intravitreal implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 12 Months ]
  • Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye [ Time Frame: Baseline, 12 Months ]
  • Average Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]

Secondary Outcome Measures:
  • Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]
  • Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]
  • Percentage of Patients with BCVA of 20/40 or Better in the Study Eye [ Time Frame: Baseline, 12 Months ]
  • Mean Number of Ozurdex Injections in the Study Eye [ Time Frame: 12 Months ]
  • Mean Time Between Ozurdex Injections in the Study Eye [ Time Frame: 12 Months ]
  • Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye [ Time Frame: Baseline, 12 Months ]

Enrollment: 200
Study Start Date: July 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dexamethasone 700 ㎍ intravitreal implant
Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
Drug: dexamethasone 700 ㎍ intravitreal implant
Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
Other Name: OZURDEX®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.
Criteria

Inclusion Criteria:

  • Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice

Exclusion Criteria:

  Contacts and Locations
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): NCT02188173


Locations
United States, Arizona
Retinal Consultants of Phoenix
Phoenix, Arizona, United States, 85014
United States, California
West Coast Retina
San Francisco, California, United States, 94109
Orange Co Retina Medical Group
Santa Ana, California, United States, 92705
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Colorado
Colorado Retina Associates
Denver, Colorado, United States, 80230
United States, Illinois
Illinois Retina Associates
Harvey, Illinois, United States, 60426
United States, Indiana
Raj Maturi, MD PC
Indianapolis, Indiana, United States, 46290
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
United States, Michigan
Associated Retina Consultants
Royal Oak, Michigan, United States, 48073
Associated Retinal Consultants, PC
Traverse City, Michigan, United States, 69686
United States, Missouri
Lifelong Vision Foundation
Chesterfield, Missouri, United States, 63017
United States, New Hampshire
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
New Jersey Retina
New Brunswick, New Jersey, United States, 08901
United States, New York
Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
Great Neck, New York, United States, 11201
United States, Pennsylvania
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19109
United States, Texas
Texas Retina Associates, Arlington
Arlington, Texas, United States, 76012
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02188173     History of Changes
Other Study ID Numbers: GMA-US-EYE-0272
REINFORCE ( Other Identifier: Allergan )
First Submitted: July 10, 2014
First Posted: July 11, 2014
Last Update Posted: June 1, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action