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

This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).

Study Overview

• Status: Completed
• Conditions: Macular Edema
• Intervention / Treatment: Drug: dexamethasone 700 ㎍ intravitreal implant

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: OZURDEX®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 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: GMA-US-EYE-0272; REINFORCE (Other Identifier: Allergan)