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This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No treatment (intervention) is being administered as part of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. | Baseline, 7 to 12 weeks following the first OZURDEX® injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warsaw | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | OZURDEX® | Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OZURDEX® | Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
| 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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. | All participants with data available at the time-point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 7 to 12 weeks following the first OZURDEX® injection |
|
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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® | Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased intraocular pressure | Investigations | 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 |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Baseline, Up to 17 Months |
| Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement. | Baseline, Up to 17 Months |
| Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | 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 | Baseline, 7 to 12 weeks following the first OZURDEX® injection |
| Time to Improvement of 2 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported. | Baseline, Up to 17 Months |
| Time to Improvement of 3 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported. | Baseline, Up to 17 Months |
| Time to OZURDEX® Re-Injection in the Study Eye | Up to 17 Months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study. |
|
|
| Secondary | Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement. | All participants. | Posted | Number | percentage of participants | Baseline, Up to 17 Months |
|
|
|
| Secondary | Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement. | All participants. | Posted | Number | percentage of participants | Baseline, Up to 17 Months |
|
|
|
| Secondary | Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | 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 | All participants with data available at the given time-point. | Posted | Mean | Standard Deviation | μm | Baseline, 7 to 12 weeks following the first OZURDEX® injection |
|
|
|
| Secondary | Time to Improvement of 2 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported. | All participants with improvement of 2 lines or more in BCVA. | Posted | Mean | Standard Deviation | days | Baseline, Up to 17 Months |
|
|
|
| Secondary | Time to Improvement of 3 Lines or More in BCVA in the Study Eye | BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported. | All participants with improvement of 3 lines or more in BCVA. | Posted | Mean | Standard Deviation | days | Baseline, Up to 17 Months |
|
|
|
| Secondary | Time to OZURDEX® Re-Injection in the Study Eye | All participants who had OZURDEX® re-injection. | Posted | Mean | Standard Deviation | days | Up to 17 Months |
|
|
|
| 0 |
| 43 |
| 29 |
| 43 |
| Ocular hypertension | Eye disorders | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Chemosis | Eye disorders | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Cortical/nuclear cataract | Eye disorders | Systematic Assessment |
|
| Subcapsular cataract | Eye disorders | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | 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.
| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |