Clinical trial NCT02188173: An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, 12 Months
measure: Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye
timeFrame: Baseline, 12 Months
measure: Average Change from Baseline in BCVA in the Study Eye
timeFrame: Baseline, 12 Months
Secondary outcomes:
measure: Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye
timeFrame: Baseline, 12 Months
measure: Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye
timeFrame: Baseline, 12 Months
measure: Percentage of Patients with BCVA of 20/40 or Better in the Study Eye
timeFrame: Baseline, 12 Months
measure: Mean Number of Ozurdex Injections in the Study Eye
timeFrame: 12 Months
measure: Mean Time Between Ozurdex Injections in the Study Eye
timeFrame: 12 Months
measure: Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye
timeFrame: Baseline, 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Phoenix
state: Arizona
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Santa Ana
country: United States
facility: Orange Co Retina Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Denver
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Harvey
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Indianapolis
country: United States
facility: Raj Maturi, MD PC
state: Indiana
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Royal Oak
country: United States
facility: Associated Retina Consultants
state: Michigan
city: Traverse City
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services
state: New Hampshire
city: New Brunswick
country: United States
facility: New Jersey Retina
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
state: New York
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Retina Associates, Arlington
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: