Macular Edema
Conditions
Brief summary
This study will 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).
Interventions
Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
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 the study eye due to BRVO or CRVO * Received at least 2 OZURDEX® injections in the study eye
Exclusion criteria
* Received OZURDEX® injections as part of or during any clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to OZURDEX® Re-injection | Up to 12 months | Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Increase of 2 Lines or More in BCVA | Baseline, Up to 12 months | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. |
| Percentage of Patients With an Increase of 3 Lines or More in BCVA | Baseline, Up to 12 months | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection | Baseline, 7 to 12 weeks following the last injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement. |
| Time to Improvement of 2 Lines or More in BCVA | Baseline, Up to 12 months | Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). |
| Time to Improvement of 3 Lines or More in BCVA | Baseline, Up to 12 months | Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). |
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection | Baseline, 7 to 12 weeks following the last injection | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. | 87 |
| Total | 87 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 68.48 Years STANDARD_DEVIATION 9.15 |
| Sex: Female, Male Female | 29 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 | 47 / 87 |
| serious Total, serious adverse events | 6 / 87 |
Outcome results
Primary
Time to OZURDEX® Re-injection
Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.
Time frame: Up to 12 months
Population: All participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Time to OZURDEX® Re-injection | 140.80 Days | Standard Deviation 56.65 |
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.
Time frame: Baseline, 7 to 12 weeks following the last injection
Population: All participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection | Baseline | 50.97 Letters | Standard Deviation 18.82 |
| All Participants | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection | Change from baseline 7-12 wks after last injection | 10.89 Letters | Standard Deviation 21.21 |
Secondary
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.
Time frame: Baseline, 7 to 12 weeks following the last injection
Population: All participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection | Baseline | 576.85 µm | Standard Deviation 204.66 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection | Change from baseline 7-12 wks after last injection | -259.21 µm | Standard Deviation 265.35 |
Secondary
Percentage of Patients With an Increase of 2 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 12 months
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Patients With an Increase of 2 Lines or More in BCVA | 56.3 Percentage of participants |
Secondary
Percentage of Patients With an Increase of 3 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 12 months
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Patients With an Increase of 3 Lines or More in BCVA | 50.6 Percentage of participants |
Secondary
Time to Improvement of 2 Lines or More in BCVA
Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
Time frame: Baseline, Up to 12 months
Population: All participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time to Improvement of 2 Lines or More in BCVA | 55.0 Days |
Secondary
Time to Improvement of 3 Lines or More in BCVA
Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
Time frame: Baseline, Up to 12 months
Population: All participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time to Improvement of 3 Lines or More in BCVA | 57.0 Days |