Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.
Interventions
DRUGdexamethasone 700 ug intravitreal implant
dexamethasone 700 ug intravitreal implant administered according to standard of care.
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
* Diagnosis of macular edema following retinal vein occlusion * Prescribed OZURDEX®
Exclusion criteria
* Previous treatment with OZURDEX®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Week 12 | BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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 change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye | Baseline, 48 Weeks | BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 2 letters or more indicates an improvement in BCVA. |
| Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye | Baseline, 48 Weeks | BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 3 letters or more indicates an improvement in BCVA. |
| Mean Change From Baseline in Central Retinal Thickness | Baseline, Week 24 | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OZURDEX® OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care. | 573 |
| Total | 573 |
Baseline characteristics
| Characteristic | OZURDEX® |
|---|---|
| Age, Customized 31 to 40 years | 4 Participants |
| Age, Customized 41 to 50 years | 13 Participants |
| Age, Customized 51 to 60 years | 69 Participants |
| Age, Customized 61 to 70 years | 127 Participants |
| Age, Customized 71 to 80 years | 235 Participants |
| Age, Customized 81 to 90 years | 119 Participants |
| Age, Customized 91 to 100 years | 6 Participants |
| Sex: Female, Male Female | 286 Participants |
| Sex: Female, Male Male | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 573 |
| serious Total, serious adverse events | 1 / 573 |
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 the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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 change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.
Time frame: Baseline, Week 12
Population: All enrolled patients with complete data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 52.431 Approximate EDTRS Letters | Standard Deviation 18.929 |
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 12 | 7.774 Approximate EDTRS Letters | Standard Deviation 14.986 |
Secondary
Mean Change From Baseline in Central Retinal Thickness
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.
Time frame: Baseline, Week 24
Population: All enrolled patients with complete data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Mean Change From Baseline in Central Retinal Thickness | Baseline | 501.18 micrometers (μm) | Standard Deviation 169.3 |
| OZURDEX® | Mean Change From Baseline in Central Retinal Thickness | Change from Baseline at Week 24 (N=138) | -61.75 micrometers (μm) | Standard Deviation 192.28 |
Secondary
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 2 letters or more indicates an improvement in BCVA.
Time frame: Baseline, 48 Weeks
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye | 46.60 Percentage of Patients |
Secondary
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 3 letters or more indicates an improvement in BCVA.
Time frame: Baseline, 48 Weeks
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye | 36.47 Percentage of Patients |