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

N/ACompletedNCT02188173

Allergan200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Interventions

dexamethasone 700 ㎍ intravitreal implantDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice Exclusion Criteria: * None

Locations (18)

Retinal Consultants of Phoenix

Phoenix, Arizona, United States

West Coast Retina

San Francisco, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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NCT02188173 - An Observational Study of OZURDEX® in Diabetic Macular Edema (DME) | Crick | Crick