Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
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 edema * Received at least 2 OZURDEX® injections
Exclusion criteria
* Received OZURDEX® injections as part of a clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | Baseline, 4 to 20 weeks after last injection (Up to 6 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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Increase of 2 Lines or More in BCVA | Baseline, Up to 6 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). An increase of 2 or more lines read correctly compared to baseline is an improvement. |
| Percentage of Participants With an Increase of 3 Lines or More in BCVA | Baseline, Up to 6 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). An increase of 3 or more lines read correctly compared to baseline is an improvement. |
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Baseline, 4 to 20 Weeks after Each injection (up to 6 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 after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. | 289 |
| Total | 289 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 71.9 Years STANDARD_DEVIATION 10.95 |
| Sex: Female, Male Female | 166 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 289 |
| serious Total, serious adverse events | 7 / 289 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.
Time frame: Baseline, 4 to 20 weeks after last injection (Up to 6 months)
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) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | Baseline | 9.8 Lines | Full Range 4.62 |
| All Participants | Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | Change from baseline at Week 4 to 20 (n=209) | 1.0 Lines | Full Range 3.51 |
Secondary
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each 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 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.
Time frame: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)
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) 4 to 20 Weeks After Each Injection | Change from baseline; second injection (n=232) | -177.6 Micron (μm) | Standard Deviation 185.21 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; third injection (n=128) | -160.9 Micron (μm) | Standard Deviation 172.98 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; eighth injection (n=1) | -75.0 Micron (μm) | — |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Baseline | 437.8 Micron (μm) | Standard Deviation 181.7 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; first injection (n=242) | -170.8 Micron (μm) | Standard Deviation 179.27 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; fourth injection (n=67) | -155.5 Micron (μm) | Standard Deviation 171.25 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; fifth injection (n=31) | -145.9 Micron (μm) | Standard Deviation 171.27 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; sixth injection (n=16) | -193.4 Micron (μm) | Standard Deviation 186.01 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; seventh injection (n=5) | -220.8 Micron (μm) | Standard Deviation 241.88 |
| All Participants | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Change from baseline; ninth injection (n=1) | -61.0 Micron (μm) | — |
Secondary
Percentage of Participants 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 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 6 months
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With an Increase of 2 Lines or More in BCVA | 62.9 Percentage of participants |
Secondary
Percentage of Participants 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 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 6 months
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With an Increase of 3 Lines or More in BCVA | 48.1 Percentage of participants |