Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
No treatment (intervention) is being administered as part of this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO) * Received at least one injection of OZURDEX® in the study eye
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, 7 to 12 weeks following the first OZURDEX® injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye | Baseline, Up to 17 Months | 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. |
| Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Baseline, 7 to 12 weeks following the first OZURDEX® 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 |
| Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye | Baseline, Up to 17 Months | 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. |
| Time to Improvement of 3 Lines or More in BCVA in the Study Eye | Baseline, Up to 17 Months | 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. |
| Time to OZURDEX® Re-Injection in the Study Eye | Up to 17 Months | — |
| Time to Improvement of 2 Lines or More in BCVA in the Study Eye | Baseline, Up to 17 Months | 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. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | OZURDEX® |
|---|---|
| Age, Continuous | 59.02 years STANDARD_DEVIATION 13.58 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
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.
Time frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Population: All participants with data available at the time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 0.22 units on a scale | Standard Deviation 0.22 |
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at 7 to 12 weeks (n=27) | 0.18 units on a scale | Standard Deviation 0.25 |
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
Time frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
Population: All participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Change from Baseline at 7 to 12 weeks (n=26) | -355.08 μm | Standard Deviation 184.72 |
| OZURDEX® | Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Baseline | 695.12 μm | Standard Deviation 212.71 |
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.
Time frame: Baseline, Up to 17 Months
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye | 63 percentage of participants |
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.
Time frame: Baseline, Up to 17 Months
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye | 53 percentage of participants |
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.
Time frame: Baseline, Up to 17 Months
Population: All participants with improvement of 2 lines or more in BCVA.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to Improvement of 2 Lines or More in BCVA in the Study Eye | 105.41 days | Standard Deviation 184.5 |
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.
Time frame: Baseline, Up to 17 Months
Population: All participants with improvement of 3 lines or more in BCVA.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to Improvement of 3 Lines or More in BCVA in the Study Eye | 100.48 days | Standard Deviation 172.84 |
Secondary
Time to OZURDEX® Re-Injection in the Study Eye
Time frame: Up to 17 Months
Population: All participants who had OZURDEX® re-injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to OZURDEX® Re-Injection in the Study Eye | 223.00 days | Standard Deviation 54.71 |