Macular Edema
Conditions
Brief summary
This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.
Interventions
DRUGDexamethasone Intravitreal Implant
Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Retinal disease involving macular edema * Received at least one OZURDEX® injection
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Baseline, 2 to 26 weeks following last injection (up to 6.5 months) | 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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 14.8 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 101 |
| serious Total, serious adverse events | 4 / 101 |
Outcome results
Primary
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.
Time frame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)
Population: All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline | 6.3 Lines | Standard Error 0.3 |
| All Participants | Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | Change from Baseline 2-26 wks after last injection | 1.4 Lines | Standard Error 0.3 |
Secondary
Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.
Time frame: Baseline, 2 to 26 weeks following last injection (up to 6.5 months)
Population: All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Baseline | 474.4 microns (μm) | Standard Error 18.2 |
| All Participants | Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Change from Baseline 2-26 wks after last injection | -183.4 microns (μm) | Standard Error 17.9 |