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This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention was administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Re-treatment | Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | BCVA was measured in the study eye using an eye chart and was 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). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with BRVO and CRVO prescribed OZURDEX®
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup Municipality | Denmark | |||||
This was a Post-Marketing Surveillance Study of OZURDEX®. 100 participants who received OZURDEX® as standard of care in clinical practice were enrolled in the study. Only 99 participants who had data recorded at Baseline and Follow-up were included in the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | OZURDEX® | Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OZURDEX® | Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Time to First Re-treatment | Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye. | All Participants with complete data. | Posted | Median | 95% Confidence Interval | days | 1 Year |
|
|
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Only Treatment-Related Adverse Events were collected in this Post Marketing Surveillance Study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OZURDEX® | Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hypertension | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| Baseline, Weeks 12, 24 and 48 |
| Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement. | Baseline, Weeks 12, 24 and 48 |
| Oslo |
| Norway |
| Uppsala | Sweden |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | BCVA was measured in the study eye using an eye chart and was 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). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved. | All participants with complete data at the given time-point. | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 12, 24 and 48 |
|
|
|
| Secondary | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement. | All participants with complete data at the given time-point. | Posted | Mean | Standard Deviation | microns | Baseline, Weeks 12, 24 and 48 |
|
|
|
| 1 |
| 99 |
| 26 |
| 99 |
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 |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 48 (n= 75) |
|
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| Change from Baseline at Week 48 (n= 70) |
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