Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone 700 ㎍ intravitreal implant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34475750 | Derived | Kim MS, Choi J, Lee HD, Woo SJ; Korea Ozurdex Post-Marketing Surveillance Study Group. Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea. Clin Ophthalmol. 2021 Aug 27;15:3623-3636. doi: 10.2147/OPTH.S302014. eCollection 2021. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population: all patients who were treated per protocol and completed a survey | Posted | Number | Patients | 4 Years |
|
Not provided
The Safety Analysis Population includes patients treated with dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant and completed a survey. The Safety Analysis Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Tension Decreased | Eye disorders | WHO-ART version 092 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 4 Years |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | Efficacy Population: all patients who were treated per protocol who had data available for analysis | Posted | Number | Percentage of Participants | 4 Years |
|
|
|
| 4 |
| 718 |
| 0 |
| 718 |
| Endophthalmitis | Eye disorders | WHO-ART version 092 | Systematic Assessment |
|
| Macula Lutea | Eye disorders | WHO-ART version 092 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |