A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema

Allergan26 sites in 2 countries82 target enrollmentSeptember 5, 2019

ConditionsDiabetic Macular Edema

InterventionsDexamethasone Intravitreal Implant

DrugsDexamethasone Intravitreal Implant

Overview

Phase: Phase 4
Intervention: Dexamethasone Intravitreal Implant
Conditions: Diabetic Macular Edema
Sponsor: Allergan
Enrollment: 82
Locations: 26
Primary Endpoint: Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.

Registry

clinicaltrials.gov

Start Date

September 5, 2019

End Date

July 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prior diagnosis of diabetes mellitus (type 1 or type 2)
•Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
•Written informed consent obtained in accordance with all local privacy requirements

Exclusion Criteria

•Uncontrolled systemic disease
•History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
•Patients who have been previously treated for DME (two focal laser allowed)
•Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
•Elevated IOP or glaucoma diagnosis
•Any active ocular infection or inflammation
•A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal)
•Anticipated need for ocular surgery during the study
•History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
•Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine

Arms & Interventions

Ozurdex

OZURDEX implant 700 μg

Intervention: Dexamethasone Intravitreal Implant

Outcomes

Primary Outcomes

Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection

Time Frame: Baseline, at Month 10 through 12

Secondary Outcomes

Time to 3rd injection(During the 12 to 14-month study)
AUC for BCVA(Baseline, During the 12 to 14-month study)
Mean number of injections administered(During the 12- to 14-month study)
Mean retreatment interval in months(During the 12 to 14-month study)
Area under the curve (AUC) for CRT(Baseline, During the 12 to 14-month study)
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)(Baseline, at Month 14)
Proportion of patients with 2nd injection(During the 12 to 14-month study)
Proportion of patients with 3rd injection(During the 12 to 14-month study)
Time to 2nd injection(During the 12 to 14-month study)
Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received(Baseline, at Month 10 through 12)