Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea
Overview
- Phase
- Not Applicable
- Intervention
- dexamethasone 700 ㎍ intravitreal implant
- Conditions
- Retinal Vein Occlusion
- Sponsor
- Allergan
- Enrollment
- 724
- Primary Endpoint
- Number of Patients With Adverse Events or Adverse Drug Reactions
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
OZURDEX®
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.
Intervention: dexamethasone 700 ㎍ intravitreal implant
Outcomes
Primary Outcomes
Number of Patients With Adverse Events or Adverse Drug Reactions
Time Frame: 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 Outcomes
- Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye(4 Years)