Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
No intervention was administered in this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Macular Edema * Prescribed OZURDEX®
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Re-treatment | 1 Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | Baseline, Weeks 12, 24 and 48 | 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. |
| Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Baseline, Weeks 12, 24 and 48 | 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. |
Countries
Denmark, Norway, Sweden
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | OZURDEX® |
|---|---|
| Age, Customized 45 to 65 years | 24 participants |
| Age, Customized < 45 years | 1 participants |
| Age, Customized > 65 years | 74 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 99 |
| serious Total, serious adverse events | 1 / 99 |
Outcome results
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.
Time frame: 1 Year
Population: All Participants with complete data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OZURDEX® | Time to First Re-treatment | 157 days |
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.
Time frame: Baseline, Weeks 12, 24 and 48
Population: All participants with complete data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | Baseline | 52.8 letters | Standard Deviation 15.61 |
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | Change from Baseline at Week 12 (n= 68) | 8.5 letters | Standard Deviation 13.16 |
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | Change from Baseline at Week 24 (n= 75) | 6.9 letters | Standard Deviation 13.01 |
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | Change from Baseline at Week 48 (n= 75) | 2.5 letters | Standard Deviation 18.61 |
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.
Time frame: Baseline, Weeks 12, 24 and 48
Population: All participants with complete data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Baseline (n- 93) | 535.2 microns | Standard Deviation 166.75 |
| OZURDEX® | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Change from Baseline at Week 12 (n= 63) | -181.3 microns | Standard Deviation 198.25 |
| OZURDEX® | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Change from Baseline at Week 24 (n= 69) | -160.4 microns | Standard Deviation 185.45 |
| OZURDEX® | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Change from Baseline at Week 48 (n= 70) | -147.7 microns | Standard Deviation 191.63 |