Macular Oedema, Retinal Vein Occlusion
Conditions
Brief summary
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.
Interventions
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) * Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to OZURDEX® Re-Injection in the Study Eye | Up to 12 Months | The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | Baseline, Up to 12 Months | 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. |
| Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | Baseline, Up to 12 Months | 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. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | Baseline, 7 to 12 weeks following the last injection | 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. |
| Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Up to 12 Months | 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. |
| Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Up to 12 Months | 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. |
| Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | Baseline, 7 to 12 weeks following the 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Previously Treated With OZURDEX® OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Patients Previously Treated With OZURDEX® |
|---|---|
| Age, Customized 41 to 50 years | 3 Participants |
| Age, Customized 51 to 60 years | 10 Participants |
| Age, Customized 61 to 70 years | 4 Participants |
| Age, Customized 71 to 80 years | 8 Participants |
| Age, Customized 81 to 90 years | 1 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: Up to 12 Months
Population: All enrolled patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Previously Treated With OZURDEX® | Time to OZURDEX® Re-Injection in the Study Eye | 143.65 Days | Standard Deviation 42.95 |
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.
Time frame: Baseline, 7 to 12 weeks following the last injection
Population: All enrolled patients with data for this data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Previously Treated With OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | Baseline | 61.75 Letters | Standard Deviation 29.02 |
| Patients Previously Treated With OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | Change from Baseline 7-12 Wks After Last Injection | -5.00 Letters | Standard Deviation 45.28 |
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.
Time frame: Baseline, 7 to 12 weeks following the last injection
Population: All enrolled patients with data for this data point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Previously Treated With OZURDEX® | Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | Baseline | 665.00 Micrometers (µm) | Standard Deviation 287.84 |
| Patients Previously Treated With OZURDEX® | Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | Change from Baseline 7-12 Wks After Last Injection | -382.17 Micrometers (µm) | Standard Deviation 285.36 |
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.
Time frame: Baseline, Up to 12 Months
Population: All enrolled patients with data for this data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Previously Treated With OZURDEX® | Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | 50.0 Percent of Participants |
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.
Time frame: Baseline, Up to 12 Months
Population: All enrolled patients with data for this data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Previously Treated With OZURDEX® | Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | 42.3 Percent of Participants |
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.
Time frame: Baseline, Up to 12 Months
Population: All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patients Previously Treated With OZURDEX® | Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | 41.0 Days | Full Range 41.49 |
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.
Time frame: Baseline, Up to 12 Months
Population: All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patients Previously Treated With OZURDEX® | Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | 41.0 Days | Full Range 45.46 |