Retinal Vein Occlusion, Macular Edema
Conditions
Brief summary
This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).
Interventions
DRUGAnti-VEGF
Patients with retinal vein occlusion or diabetic macular edema receiving anti-VEGF injection(s) in accordance with standard of care practices. This is a retrospective chart review study.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Macular edema in the study eye due to RVO or DME * Received an anti-VEGF injection in the study eye on or after June 2010 for RVO and on or after August 2012 for DME
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2 | Up to Time of Injection 2 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3 | Up to Time of Injection 3 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4 | Up to Time of Injection 4 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5 | Up to Time of Injection 5 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6 | Up to Time of Injection 6 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7 | Up to Time of Injection 7 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8 | Up to Time of Injection 8 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9 | Up to Time of Injection 9 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10 | Up to Time of Injection 10 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11 | Up to Time of Injection 11 (Up to 4 Years) | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to 4 Years | 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). 20/40 or better is equivalent to 14 or more lines read correctly |
| Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to 4 Years | CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to 4 Years | 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Mean BCVA in the Study Eye | UP to 4 Years | 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). |
| Change From Baseline in BCVA in the Study Eye | Baseline, Up to 4 Years | 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). A positive change from Baseline indicates improvement. |
| Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Baseline, Up to 4 Years | 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 from Baseline indicates improvement. |
| Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Baseline, Up to 4 Years | 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 from Baseline indicates improvement. |
| Change From Baseline in CRT by OCT in the Study Eye | Baseline, Up to 4 Years | CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement. |
| Time to Improvement of ≥2 Lines in BCVA in the Study Eye | 4 Years | Kaplan-Meier estimates of the time in months to improvement of ≥2 lines 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). |
| Time to Improvement of ≥3 Lines in BCVA in the Study Eye | 4 Years | Kaplan-Meier estimates of the time in months to improvement of ≥3 lines 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). |
| Time to Improvement in BCVA to 20/40 or Better in the Study Eye | 4 Years | Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. 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). 20/40 or better is equivalent to 14 or more lines read correctly. |
| Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 4 Years | Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 4 Years | Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. |
| Time Between Anti-VEGF Injections in the Study Eye | 4 Years | The mean time in months between anti-VEGF Injections. |
| Number of Intravitreal Anti-VEGF Injections in the Study Eye | 0-6 Months, 7-12 Months, Years 1,2,3 | To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period. |
| Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye | UP to 4 Years | — |
| Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | Up to 4 Years | Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept. |
| Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye | 4 Years | — |
| Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye | 4 Years | — |
| Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Baseline, Up to 4 Years | 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). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision. |
| Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Baseline, Up to 4 Years | 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). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision. |
| Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Baseline, Up to 4 Years | 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). |
| Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye | 4 Years | — |
| Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye | 4 Years | — |
| Percentage of Phakic Patients With Cataract Surgery in the Study Eye | 4 Years | Phakic patients have intraocular lens implants. |
Countries
United States
Participant flow
Pre-assignment details
323 patients were enrolled in the study and were divided into 2 groups based on their diagnosis: 166 patients with Retinal Vein Occlusion and 157 patients with Diabetic Macular Edema. 2 patients (1 in each group) were missing data and are not included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Patients With RVO Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study. | 165 |
| Patients With DME Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study. | 156 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing Data | 1 | 1 |
Baseline characteristics
| Characteristic | Patients With RVO | Patients With DME | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years FULL_RANGE 13.62 | 63.4 years FULL_RANGE 11.29 | 66.4 years |
| Sex: Female, Male Female | 80 Participants | 72 Participants | 152 Participants |
| Sex: Female, Male Male | 85 Participants | 84 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 165 | 0 / 156 |
| serious Total, serious adverse events | 12 / 165 | 12 / 156 |
Outcome results
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 10 (Up to 4 Years)
Population: All participants with data available up to time of Injection 10.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10 | 28.57 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10 | 22.22 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 11 (Up to 4 Years)
Population: All participants with data available up to time of Injection 11.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11 | 28.30 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11 | 38.89 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 2 (Up to 4 Years)
Population: All participants with data available up to time of Injection 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2 | 26.09 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2 | 16.35 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 3 (Up to 4 Years)
Population: All participants with data available up to time of Injection 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3 | 28.81 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3 | 16.36 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 4 (Up to 4 Years)
Population: All participants with data available up to time of Injection 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4 | 26.56 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4 | 17.54 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 5 (Up to 4 Years)
Population: All participants with data available up to time of Injection 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5 | 36.59 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5 | 22.11 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 6 (Up to 4 Years)
Population: All participants with data available up to time of Injection 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6 | 25.47 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6 | 19.48 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 7 (Up to 4 Years)
Population: All participants with data available up to time of Injection 7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7 | 32.29 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7 | 20.00 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 8 (Up to 4 Years)
Population: All participants with data available up to time of Injection 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8 | 25.97 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8 | 18.75 percentage of participants |
Primary
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to Time of Injection 9 (Up to 4 Years)
Population: All participants with data available up to time of Injection 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9 | 32.81 percentage of participants |
| Patients With DME | Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9 | 24.39 percentage of participants |
Secondary
Change From Baseline in BCVA in the Study Eye
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). A positive change from Baseline indicates improvement.
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 4 (n=118,109) | 1.6 lines | Standard Deviation 3.37 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 7 (n=89,69) | 2.1 lines | Standard Deviation 4.04 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 3 (n=115,117) | 1.9 lines | Standard Deviation 3.33 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 8 (n=73,43) | 1.7 lines | Standard Deviation 4.32 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 5 (n=109,98) | 1.7 lines | Standard Deviation 4.02 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 9 (n=66,37) | 1.9 lines | Standard Deviation 4 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 2(n=116,114) | 1.6 lines | Standard Deviation 3.12 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 10 (n=58,33) | 1.8 lines | Standard Deviation 3.96 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 6 (n=101,86) | 1.9 lines | Standard Deviation 4.18 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 11 (n=49,17) | 1.4 lines | Standard Deviation 4.21 |
| Patients With RVO | Change From Baseline in BCVA in the Study Eye | Baseline (n=133,130) | 10.6 lines | Standard Deviation 4.04 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 11 (n=49,17) | 0.4 lines | Standard Deviation 3.73 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Baseline (n=133,130) | 11.8 lines | Standard Deviation 3.5 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 2(n=116,114) | 1.0 lines | Standard Deviation 2.46 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 3 (n=115,117) | 1.3 lines | Standard Deviation 2.63 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 4 (n=118,109) | 1.1 lines | Standard Deviation 2.51 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 5 (n=109,98) | 1.3 lines | Standard Deviation 2.62 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 6 (n=101,86) | 1.2 lines | Standard Deviation 2.48 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 7 (n=89,69) | 1.1 lines | Standard Deviation 2.31 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 8 (n=73,43) | 0.8 lines | Standard Deviation 2.65 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 9 (n=66,37) | 1.5 lines | Standard Deviation 3.19 |
| Patients With DME | Change From Baseline in BCVA in the Study Eye | Change from Baseline Up to Injection 10 (n=58,33) | 1.3 lines | Standard Deviation 3.46 |
Secondary
Change From Baseline in CRT by OCT in the Study Eye
CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection4 (n=117,104) | -151.9 µm (microns) | Standard Deviation 204.1 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 7 (n=85,67) | -171.5 µm (microns) | Standard Deviation 225.49 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 3 (n=110,95) | -158.6 µm (microns) | Standard Deviation 188.06 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 8 (n=70,47) | -202.7 µm (microns) | Standard Deviation 191.62 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 5 (n=109,84) | -169.4 µm (microns) | Standard Deviation 211.28 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 9 (n=63,37) | -224.2 µm (microns) | Standard Deviation 186.64 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 2 (n=110,95) | -159.5 µm (microns) | Standard Deviation 183.98 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 10 (n=65,31) | -210.0 µm (microns) | Standard Deviation 226.05 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 6 (n=93,68) | -180.8 µm (microns) | Standard Deviation 223.14 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 11 (n=48,18) | -212.4 µm (microns) | Standard Deviation 207.39 |
| Patients With RVO | Change From Baseline in CRT by OCT in the Study Eye | Baseline (n=128,119) | 499.1 µm (microns) | Standard Deviation 188.14 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 11 (n=48,18) | -76.0 µm (microns) | Standard Deviation 119.54 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Baseline (n=128,119) | 413.4 µm (microns) | Standard Deviation 104.85 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 2 (n=110,95) | -44.7 µm (microns) | Standard Deviation 93.62 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 3 (n=110,95) | -62.1 µm (microns) | Standard Deviation 100.61 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection4 (n=117,104) | -66.8 µm (microns) | Standard Deviation 102.31 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 5 (n=109,84) | -55.7 µm (microns) | Standard Deviation 82.23 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 6 (n=93,68) | -63.0 µm (microns) | Standard Deviation 89.54 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 7 (n=85,67) | -70.1 µm (microns) | Standard Deviation 97.13 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 8 (n=70,47) | -82.5 µm (microns) | Standard Deviation 103.79 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 9 (n=63,37) | -66.4 µm (microns) | Standard Deviation 108.21 |
| Patients With DME | Change From Baseline in CRT by OCT in the Study Eye | Change from Baseline Up to Injection 10 (n=65,31) | -60.9 µm (microns) | Standard Deviation 105.07 |
Secondary
Mean BCVA in the Study Eye
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).
Time frame: UP to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 12.4 lines | Standard Deviation 4.09 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 12.5 lines | Standard Deviation 3.97 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 13.0 lines | Standard Deviation 3.56 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 12.3 lines | Standard Deviation 4.12 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 12.7 lines | Standard Deviation 3.87 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 12.7 lines | Standard Deviation 3.8 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 12.7 lines | Standard Deviation 3.69 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 12.3 lines | Standard Deviation 3.49 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 12.5 lines | Standard Deviation 3.82 |
| Patients With RVO | Mean BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 12.1 lines | Standard Deviation 3.83 |
| Patients With RVO | Mean BCVA in the Study Eye | Baseline (n=133,130) | 10.6 lines | Standard Deviation 4.04 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 12.0 lines | Standard Deviation 4.88 |
| Patients With DME | Mean BCVA in the Study Eye | Baseline (n=133,130) | 11.8 lines | Standard Deviation 3.5 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 12.8 lines | Standard Deviation 3.38 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 12.9 lines | Standard Deviation 2.97 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 12.9 lines | Standard Deviation 3.2 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 13.0 lines | Standard Deviation 3.02 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 12.9 lines | Standard Deviation 2.89 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 12.8 lines | Standard Deviation 3.18 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 12.8 lines | Standard Deviation 3.37 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 12.7 lines | Standard Deviation 3.52 |
| Patients With DME | Mean BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 12.3 lines | Standard Deviation 3.81 |
Secondary
Number of Intravitreal Anti-VEGF Injections in the Study Eye
To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.
Time frame: 0-6 Months, 7-12 Months, Years 1,2,3
Population: All participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With RVO | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 3 (n = 17,10) | 5.9 injections | Standard Deviation 2.99 |
| Patients With RVO | Number of Intravitreal Anti-VEGF Injections in the Study Eye | 0-6 Months (n = 158,149) | 4.4 injections | Standard Deviation 1.4 |
| Patients With RVO | Number of Intravitreal Anti-VEGF Injections in the Study Eye | 7-12 Months (n = 99,64) | 3.3 injections | Standard Deviation 1.64 |
| Patients With RVO | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 1 (n = 117,80) | 7.1 injections | Standard Deviation 2.9 |
| Patients With RVO | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 2 (n = 40,23) | 5.4 injections | Standard Deviation 2.98 |
| Patients With DME | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 2 (n = 40,23) | 5.0 injections | Standard Deviation 2.65 |
| Patients With DME | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 1 (n = 117,80) | 5.8 injections | Standard Deviation 2.77 |
| Patients With DME | Number of Intravitreal Anti-VEGF Injections in the Study Eye | 0-6 Months (n = 158,149) | 4.0 injections | Standard Deviation 1.64 |
| Patients With DME | Number of Intravitreal Anti-VEGF Injections in the Study Eye | Year 3 (n = 17,10) | 3.4 injections | Standard Deviation 1.96 |
| Patients With DME | Number of Intravitreal Anti-VEGF Injections in the Study Eye | 7-12 Months (n = 99,64) | 2.8 injections | Standard Deviation 1.42 |
Secondary
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.
Time frame: Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | bevacizumab to aflibercept | 2.67 percentage of participants |
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | bevacizumab to ranibizumab | 13.33 percentage of participants |
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | aflibercept to bevacizumab | 4.00 percentage of participants |
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | aflibercept to ranibizumab | 20.00 percentage of participants |
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | ranibizumab to bevacizumab | 53.33 percentage of participants |
| Patients With RVO | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | ranibizumab to aflibercept | 6.67 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | ranibizumab to bevacizumab | 73.68 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | bevacizumab to aflibercept | 0.0 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | aflibercept to ranibizumab | 1.05 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | bevacizumab to ranibizumab | 25.26 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | ranibizumab to aflibercept | 0.0 percentage of participants |
| Patients With DME | Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye | aflibercept to bevacizumab | 0.0 percentage of participants |
Secondary
Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye
Time frame: UP to 4 Years
Population: All participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye | 33.33 percentage of participants |
| Patients With DME | Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye | 47.44 percentage of participants |
Secondary
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
Time frame: 4 Years
Population: All participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye | 20.00 percentage of participants |
| Patients With DME | Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye | 44.87 percentage of participants |
Secondary
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
Time frame: 4 Years
Population: All participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye | 0.61 percentage of participants |
| Patients With DME | Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye | 0.64 percentage of participants |
Secondary
Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
Time frame: 4 Years
Population: All participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye | 1.21 percentage of participants |
| Patients With DME | Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye | 0.00 percentage of participants |
Secondary
Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
Time frame: 4 Years
Population: All participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye | 5.45 percentage of participants |
| Patients With DME | Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye | 13.46 percentage of participants |
Secondary
Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye
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). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 58.99 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 61.70 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 55.32 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 53.73 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 55.83 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 58.88 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 54.65 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 59.46 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 60.00 percentage of participants |
| Patients With RVO | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 55.36 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 44.44 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 45.86 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 45.57 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 53.33 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 39.13 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 47.29 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 45.28 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 50.44 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 41.03 percentage of participants |
| Patients With DME | Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 44.55 percentage of participants |
Secondary
Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye
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). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 13.67 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 14.18 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 20.57 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 20.15 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 17.50 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 18.69 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 16.28 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 14.86 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 21.54 percentage of participants |
| Patients With RVO | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 23.21 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 17.78 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 15.79 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 18.99 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 21.48 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 13.04 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 23.26 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 22.64 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 15.04 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 20.51 percentage of participants |
| Patients With DME | Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 19.80 percentage of participants |
Secondary
Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye
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 from Baseline indicates improvement.
Time frame: Baseline, Up to 4 Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 40.29 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 40.43 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 40.43 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 40.30 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 40.83 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 46.73 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 46.51 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 50.00 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 47.69 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 41.07 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 33.33 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 30.08 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 35.44 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 35.56 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 21.74 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 29.46 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 28.30 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 32.74 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 33.33 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 25.74 percentage of participants |
Secondary
Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye
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 from Baseline indicates improvement.
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 25.90 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 28.37 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 25.53 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 32.09 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 30.83 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 36.45 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 30.23 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 40.54 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 40.00 percentage of participants |
| Patients With RVO | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 35.71 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 9 (n=74,45) | 28.89 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 2 (n=139,133) | 14.29 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 7 (n=107,79) | 21.52 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 3 (n=141,135) | 20.00 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 11 (n=56,23) | 17.39 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 4 (n=141,129) | 17.83 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 8 (n=86,53) | 22.64 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 5 (n=134,113) | 20.35 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 10 (n=65,39) | 28.21 percentage of participants |
| Patients With DME | Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye | Up to Time of Injection 6 (n=120,101) | 19.80 percentage of participants |
Secondary
Percentage of Participants With BCVA of 20/40 or Better in the Study Eye
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). 20/40 or better is equivalent to 14 or more lines read correctly
Time frame: Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 2 (n=139,133) | 53.24 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 3 (n=141,135) | 53.19 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 4 (n=141,129) | 50.35 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 5 (n=134,113) | 56.72 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 6 (n=120,101) | 47.50 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 7 (n=107,79) | 48.60 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 8 (n=86,53) | 46.51 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 9 (n=74,45) | 52.70 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 10 (n=65,39) | 43.08 percentage of participants |
| Patients With RVO | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 11 (n=56,23) | 44.64 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 9 (n=74,45) | 55.56 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 2 (n=139,133) | 54.89 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 7 (n=107,79) | 54.43 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 3 (n=141,135) | 53.33 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 11 (n=56,23) | 56.52 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 4 (n=141,129) | 51.94 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 8 (n=86,53) | 62.26 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 5 (n=134,113) | 56.64 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 10 (n=65,39) | 53.85 percentage of participants |
| Patients With DME | Percentage of Participants With BCVA of 20/40 or Better in the Study Eye | Up to Time of Injection 6 (n=120,101) | 55.45 percentage of participants |
Secondary
Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 2 (n=157,147) | 70.06 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 3 (n=157,147) | 73.25 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 4(n=158,144) | 71.52 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 5 (n=148,124) | 75.68 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 6 (n=129,107) | 71.32 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 7 (n=115,89) | 69.57 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 8 (n=94,66) | 72.34 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 9 (n=84,51) | 77.38 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 10 (n=76,46) | 77.63 percentage of participants |
| Patients With RVO | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 11 (n=61,30) | 77.05 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 9 (n=84,51) | 58.82 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 2 (n=157,147) | 59.86 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 7 (n=115,89) | 60.67 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 3 (n=157,147) | 57.82 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 11 (n=61,30) | 60.00 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 4(n=158,144) | 58.33 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 8 (n=94,66) | 60.61 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 5 (n=148,124) | 62.10 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 10 (n=76,46) | 54.35 percentage of participants |
| Patients With DME | Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 6 (n=129,107) | 63.55 percentage of participants |
Secondary
Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 2 (n=133,118) | 50.38 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 3 (n=134,122) | 56.72 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 4 (n=145,129) | 53.10 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 5 (n=137,106) | 59.12 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 6 (n=115,83) | 54.78 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 7 (n=104,80) | 56.73 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 8 (n=85,61) | 57.65 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 9 (n=74,47) | 63.51 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 10(n=74,43) | 67.57 percentage of participants |
| Patients With RVO | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 11(n=58,25) | 63.79 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 9 (n=74,47) | 31.91 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 2 (n=133,118) | 28.81 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 7 (n=104,80) | 31.25 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 3 (n=134,122) | 26.23 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 11(n=58,25) | 48.0 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 4 (n=145,129) | 29.46 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 8 (n=85,61) | 27.87 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 5 (n=137,106) | 33.02 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 10(n=74,43) | 27.91 percentage of participants |
| Patients With DME | Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | Up to Time of Injection 6 (n=115,83) | 33.73 percentage of participants |
Secondary
Percentage of Participants With No Change in BCVA From Baseline in the Study Eye
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).
Time frame: Baseline, Up to 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 17.99 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 14.89 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 16.31 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 17.16 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 16.67 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 12.15 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 18.60 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 18.92 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 13.85 percentage of participants |
| Patients With RVO | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 16.07 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 9 (n=74,45) | 31.11 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 2 (n=139,133) | 34.59 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 7 (n=107,79) | 30.38 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 3 (n=141,135) | 19.26 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 11 (n=56,23) | 21.74 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 4 (n=141,129) | 25.58 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 8 (n=86,53) | 18.87 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 5 (n=134,113) | 24.78 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 10 (n=65,39) | 30.77 percentage of participants |
| Patients With DME | Percentage of Participants With No Change in BCVA From Baseline in the Study Eye | Up to Time of Injection 6 (n=120,101) | 23.76 percentage of participants |
Secondary
Percentage of Phakic Patients With Cataract Surgery in the Study Eye
Phakic patients have intraocular lens implants.
Time frame: 4 Years
Population: All phakic participants with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With RVO | Percentage of Phakic Patients With Cataract Surgery in the Study Eye | 17.0 percentage of participants |
| Patients With DME | Percentage of Phakic Patients With Cataract Surgery in the Study Eye | 15.0 percentage of participants |
Secondary
Time Between Anti-VEGF Injections in the Study Eye
The mean time in months between anti-VEGF Injections.
Time frame: 4 Years
Population: All participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 5 (n=143,124) | 1.3 months | Standard Deviation 0.73 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 2 (n=163,152) | 1.1 months | Standard Deviation 0.57 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 3 (n=162,154) | 1.1 months | Standard Deviation 0.6 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 4 (n=157,141) | 1.4 months | Standard Deviation 1.1 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 6 (n=127,106) | 1.4 months | Standard Deviation 1.19 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 7 (n=114,89) | 1.5 months | Standard Deviation 1.7 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 8 (n=99,64) | 1.6 months | Standard Deviation 3.11 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 9 (n=82,52) | 1.3 months | Standard Deviation 0.78 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 10 (n=73,40) | 1.4 months | Standard Deviation 0.57 |
| Patients With RVO | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 11 (n=63,30) | 1.3 months | Standard Deviation 0.53 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 9 (n=82,52) | 1.4 months | Standard Deviation 1.12 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 7 (n=114,89) | 1.5 months | Standard Deviation 1.2 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 2 (n=163,152) | 1.5 months | Standard Deviation 1.38 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 11 (n=63,30) | 1.2 months | Standard Deviation 0.8 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 3 (n=162,154) | 1.6 months | Standard Deviation 1.32 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 8 (n=99,64) | 1.3 months | Standard Deviation 0.59 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 4 (n=157,141) | 1.7 months | Standard Deviation 1.49 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 5 (n=143,124) | 1.4 months | Standard Deviation 0.97 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 10 (n=73,40) | 1.2 months | Standard Deviation 0.64 |
| Patients With DME | Time Between Anti-VEGF Injections in the Study Eye | Up to Time of Injection 6 (n=127,106) | 1.3 months | Standard Deviation 0.6 |
Secondary
Time to Improvement in BCVA to 20/40 or Better in the Study Eye
Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. 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). 20/40 or better is equivalent to 14 or more lines read correctly.
Time frame: 4 Years
Population: All participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With RVO | Time to Improvement in BCVA to 20/40 or Better in the Study Eye | 2.3167 months |
| Patients With DME | Time to Improvement in BCVA to 20/40 or Better in the Study Eye | 3.3667 months |
Secondary
Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: 4 Years
Population: All participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With RVO | Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 2.5333 months |
| Patients With DME | Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 7.9333 months |
Secondary
Time to Improvement of ≥2 Lines in BCVA in the Study Eye
Kaplan-Meier estimates of the time in months to improvement of ≥2 lines 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).
Time frame: 4 Years
Population: All participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With RVO | Time to Improvement of ≥2 Lines in BCVA in the Study Eye | 4.6667 months |
| Patients With DME | Time to Improvement of ≥2 Lines in BCVA in the Study Eye | 7.1500 months |
Secondary
Time to Improvement of ≥3 Lines in BCVA in the Study Eye
Kaplan-Meier estimates of the time in months to improvement of ≥3 lines 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).
Time frame: 4 Years
Population: All participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With RVO | Time to Improvement of ≥3 Lines in BCVA in the Study Eye | 7.2167 months |
| Patients With DME | Time to Improvement of ≥3 Lines in BCVA in the Study Eye | 9.1000 months |
Secondary
Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. 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). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time frame: 4 Years
Population: All participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With RVO | Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 7.6167 months |
| Patients With DME | Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye | 9.8000 months |