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
The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Previously Treated with OZURDEX® | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant 0.7 mg | Drug | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to OZURDEX® Re-Injection in the Study Eye | The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye. | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | BCVA is measured in the study eye following each injection of OZURDEX® using a special 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). 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 has improved. Data are reported for the 7-12 week period following the last injection. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients Previously Treated With OZURDEX® | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 7 to 12 weeks following the last injection |
| Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | Baseline, Up to 12 Months |
| Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | Baseline, Up to 12 Months |
| Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection. | Baseline, 7 to 12 weeks following the last injection |
| Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | Baseline, Up to 12 Months |
| Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | Baseline, Up to 12 Months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients Previously Treated With OZURDEX® | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 OZURDEX® Re-Injection in the Study Eye | The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye. | All enrolled patients. | Posted | Mean | Standard Deviation | Days | Up to 12 Months |
|
|
| |||||||||||||||||||||||||
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | BCVA is measured in the study eye following each injection of OZURDEX® using a special 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). 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 has improved. Data are reported for the 7-12 week period following the last injection. | All enrolled patients with data for this data point. | Posted | Mean | Standard Deviation | Letters | Baseline, 7 to 12 weeks following the last injection |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | All enrolled patients with data for this data point. | Posted | Number | Percent of Participants | Baseline, Up to 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | All enrolled patients with data for this data point. | Posted | Number | Percent of Participants | Baseline, Up to 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection. | All enrolled patients with data for this data point. | Posted | Mean | Standard Deviation | Micrometers (µm) | Baseline, 7 to 12 weeks following the last injection |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA. | Posted | Median | Full Range | Days | Baseline, Up to 12 Months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA. | Posted | Median | Full Range | Days | Baseline, Up to 12 Months |
|
|
All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs). This was a retrospective study. Patient charts were reviewed for AEs.
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 | Patients Previously Treated With OZURDEX® | OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. | 0 | 26 | 20 | 26 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lenticular Opacities | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Ocular Hypertension | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Intraocular Pressure Increased | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Cataract Operation | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Eye Laser Surgery | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Macular Fibrosis | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA version 14.1 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 71 to 80 years |
|
| 81 to 90 years |
|
|
|
|
|
|
|