An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
- Registration Number
- NCT02188173
- Lead Sponsor
- Allergan
- Brief Summary
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dexamethasone 700 ㎍ intravitreal implant 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (18)
Raj Maturi, MD PC
🇺🇸Indianapolis, Indiana, United States
Texas Retina Associates, Arlington
🇺🇸Arlington, Texas, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
🇺🇸Great Neck, New York, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Associated Retinal Consultants, PC
🇺🇸Traverse City, Michigan, United States
Associated Retina Consultants
🇺🇸Royal Oak, Michigan, United States
New Jersey Retina
🇺🇸New Brunswick, New Jersey, United States
Eyesight Ophthalmic Services
🇺🇸Portsmouth, New Hampshire, United States
Illinois Retina Associates
🇺🇸Harvey, Illinois, United States
Retinal Consultants of Phoenix
🇺🇸Phoenix, Arizona, United States
West Coast Retina
🇺🇸San Francisco, California, United States
Orange Co Retina Medical Group
🇺🇸Santa Ana, California, United States
Colorado Retina Associates
🇺🇸Denver, Colorado, United States