A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

Allergan0 sites87 target enrollmentOctober 2011

ConditionsMacular Edema

Interventionsdexamethasone intravitreal implant 0.7 mg

Drugsdexamethasone intravitreal implant 0.7 mg

Overview

Phase: Not Applicable
Intervention: dexamethasone intravitreal implant 0.7 mg
Conditions: Macular Edema
Sponsor: Allergan
Enrollment: 87
Primary Endpoint: Time to OZURDEX® Re-injection
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will 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).

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

January 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Macular oedema in the study eye due to BRVO or CRVO
•Received at least 2 OZURDEX® injections in the study eye

Exclusion Criteria

•Received OZURDEX® injections as part of or during any clinical study

Arms & Interventions

All participants

Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.

Intervention: dexamethasone intravitreal implant 0.7 mg

Outcomes

Primary Outcomes

Time to OZURDEX® Re-injection

Time Frame: Up to 12 months

Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.

Secondary Outcomes

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