N/A
Completed N=724
Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea
Source: ClinicalTrials.gov NCT01976650 ↗Enrolled (actual)
724
Serious AEs
0.6%
Results posted
Jan 2016
Primary outcomePrimary: Number of Patients With Adverse Events or Adverse Drug Reactions — 55; 50 Patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events or Adverse Drug Reactions |
55; 50 | — |
| SECONDARY Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye |
94.36 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01976650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.