An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
2 other identifiers
observational
200
1 country
18
Brief Summary
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 1, 2016
May 1, 2016
1.8 years
July 10, 2014
May 31, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.
You may qualify if:
- Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (18)
Retinal Consultants of Phoenix
Phoenix, Arizona, 85014, United States
West Coast Retina
San Francisco, California, 94109, United States
Orange Co Retina Medical Group
Santa Ana, California, 92705, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Colorado Retina Associates
Denver, Colorado, 80230, United States
Illinois Retina Associates
Harvey, Illinois, 60426, United States
Raj Maturi, MD PC
Indianapolis, Indiana, 46290, United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Associated Retina Consultants
Royal Oak, Michigan, 48073, United States
Associated Retinal Consultants, PC
Traverse City, Michigan, 69686, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801, United States
New Jersey Retina
New Brunswick, New Jersey, 08901, United States
Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
Great Neck, New York, 11201, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19109, United States
Texas Retina Associates, Arlington
Arlington, Texas, 76012, United States
Valley Retina Institute, P.A.
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2014
First Posted
July 11, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 1, 2016
Record last verified: 2016-05