Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

Allergan0 sites26 target enrollmentMarch 2012

ConditionsRetinal Vein Occlusion Macular Oedema

Interventionsdexamethasone intravitreal implant 0.7 mg

Drugsdexamethasone intravitreal implant 0.7 mg

Overview

Phase: Not Applicable
Intervention: dexamethasone intravitreal implant 0.7 mg
Conditions: Retinal Vein Occlusion
Sponsor: Allergan
Enrollment: 26
Primary Endpoint: Time to OZURDEX® Re-Injection in the Study Eye
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

June 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
•Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion Criteria

Not provided

Arms & Interventions

Patients Previously Treated with OZURDEX®

OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Intervention: dexamethasone intravitreal implant 0.7 mg

Outcomes

Primary Outcomes

Time to OZURDEX® Re-Injection in the Study Eye

Time Frame: Up to 12 Months

The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

Secondary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye(Baseline, 7 to 12 weeks following the last injection)
Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye(Baseline, Up to 12 Months)
Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye(Baseline, Up to 12 Months)
Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection(Baseline, 7 to 12 weeks following the last injection)
Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Up to 12 Months)
Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Up to 12 Months)