Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: dexamethasone 700 ㎍ intravitreal implant

• Registration Number: NCT01976650
• Lead Sponsor: Allergan

Brief Summary

This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-12
• Results First Submitted: 2015-12-08
• Results First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Results First Posted: 2016-01-13
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 724

Inclusion Criteria

• Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.

Exclusion Criteria

• Patients with eye infections
• Patients with glaucoma.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	dexamethasone 700 ㎍ intravitreal implant	Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events or Adverse Drug Reactions	4 Years	An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	4 Years	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.