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

Allergan18 sites in 1 country200 target enrollmentJuly 2014

ConditionsMacular Edema

Interventionsdexamethasone 700 ㎍ intravitreal implant

Drugsdexamethasone 700 ㎍ intravitreal implant

Overview

Phase: Not Applicable
Intervention: dexamethasone 700 ㎍ intravitreal implant
Conditions: Macular Edema
Sponsor: Allergan
Enrollment: 200
Locations: 18
Primary Endpoint: Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

May 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

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.

Intervention: dexamethasone 700 ㎍ intravitreal implant

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(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)