Retinal Vein Occlusion
Conditions
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.
Interventions
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.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Pre-assignment details
The Enrolled Population includes all 724 patients consented. The Safety Analysis Population includes 718 patients who were treated per protocol and completed a survey. The Safety Analysis Population was used for all analyses.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 718 |
| Total | 718 |
Baseline characteristics
| Characteristic | OZURDEX® |
|---|---|
| Age, Continuous | 62.18 Years STANDARD_DEVIATION 11.14 |
| Sex: Female, Male Female | 424 Participants |
| Sex: Female, Male Male | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 718 |
| serious Total, serious adverse events | 4 / 718 |
Outcome results
Primary
Number of Patients With Adverse Events or Adverse Drug Reactions
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.
Time frame: 4 Years
Population: Safety Population: all patients who were treated per protocol and completed a survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OZURDEX® | Number of Patients With Adverse Events or Adverse Drug Reactions | Adverse Events | 55 Patients |
| OZURDEX® | Number of Patients With Adverse Events or Adverse Drug Reactions | Adverse Drug Reactions | 50 Patients |
Secondary
Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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.
Time frame: 4 Years
Population: Efficacy Population: all patients who were treated per protocol who had data available for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 94.36 Percentage of Participants |