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This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-VEGF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Time of Injection 2 (Up to 4 Years) |
| 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. | Up to Time of Injection 3 (Up to 4 Years) |
| 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. | Up to Time of Injection 4 (Up to 4 Years) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Received Anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29662298 | Background | Jumper JM, Dugel PU, Chen S, Blinder KJ, Walt JG. Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2). Clin Ophthalmol. 2018 Apr 3;12:621-629. doi: 10.2147/OPTH.S163859. eCollection 2018. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants with data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Patients With DME |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with data available up to time of Injection 2. | Posted | Number | percentage of participants | Up to Time of Injection 2 (Up to 4 Years) |
|
Up to 4 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| Up to Time of Injection 5 (Up to 4 Years) |
| 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. | Up to Time of Injection 6 (Up to 4 Years) |
| 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. | Up to Time of Injection 7 (Up to 4 Years) |
| 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. | Up to Time of Injection 8 (Up to 4 Years) |
| 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. | Up to Time of Injection 9 (Up to 4 Years) |
| 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. | Up to Time of Injection 10 (Up to 4 Years) |
| 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. | Up to Time of Injection 11 (Up to 4 Years) |
| 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. |
| Up to 4 Years |
| 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. | Up to 4 Years |
| 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). | UP to 4 Years |
| 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. | Baseline, Up to 4 Years |
| 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. | Baseline, Up to 4 Years |
| 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. | Baseline, Up to 4 Years |
| 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. | Baseline, Up to 4 Years |
| 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). | 4 Years |
| 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). | 4 Years |
| 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. | 4 Years |
| 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. | 4 Years |
| 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. | 4 Years |
| Time Between Anti-VEGF Injections in the Study Eye | The mean time in months between anti-VEGF Injections. | 4 Years |
| 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. | 0-6 Months, 7-12 Months, Years 1,2,3 |
| 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 | Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept. | Up to 4 Years |
| 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 | 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. | Baseline, Up to 4 Years |
| 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. | Baseline, Up to 4 Years |
| 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). | Baseline, Up to 4 Years |
| 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 | Phakic patients have intraocular lens implants. | 4 Years |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
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| 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. | All participants with data available up to time of Injection 3. | Posted | Number | percentage of participants | Up to Time of Injection 3 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 4. | Posted | Number | percentage of participants | Up to Time of Injection 4 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 5. | Posted | Number | percentage of participants | Up to Time of Injection 5 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 6. | Posted | Number | percentage of participants | Up to Time of Injection 6 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 7. | Posted | Number | percentage of participants | Up to Time of Injection 7 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 8. | Posted | Number | percentage of participants | Up to Time of Injection 8 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 9. | Posted | Number | percentage of participants | Up to Time of Injection 9 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 10. | Posted | Number | percentage of participants | Up to Time of Injection 10 (Up to 4 Years) |
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| 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. | All participants with data available up to time of Injection 11. | Posted | Number | percentage of participants | Up to Time of Injection 11 (Up to 4 Years) |
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| 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 | All participants with data available. | Posted | Number | percentage of participants | Up to 4 Years |
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Up to 4 Years |
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Up to 4 Years |
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| 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). | All participants with data available. | Posted | Mean | Standard Deviation | lines | UP to 4 Years |
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| 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. | All participants with data available. | Posted | Mean | Standard Deviation | lines | Baseline, Up to 4 Years |
|
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| 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. | Posted | Number | percentage of participants | Baseline, Up to 4 Years |
|
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Baseline, Up to 4 Years |
|
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| 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. | All participants with data available. | Posted | Mean | Standard Deviation | µm (microns) | Baseline, Up to 4 Years |
|
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| 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). | All participants with available data. | Posted | Median | Full Range | months | 4 Years |
|
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| 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). | All participants with available data. | Posted | Median | Full Range | months | 4 Years |
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| 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. | All participants with available data. | Posted | Median | Full Range | months | 4 Years |
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| 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. | All participants with available data. | Posted | Median | Full Range | months | 4 Years |
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| 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. | All participants with available data. | Posted | Median | Full Range | months | 4 Years |
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| Secondary | Time Between Anti-VEGF Injections in the Study Eye | The mean time in months between anti-VEGF Injections. | All participants with data available. | Posted | Mean | Standard Deviation | months | 4 Years |
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|
| 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. | All participants with data available. | Posted | Mean | Standard Deviation | injections | 0-6 Months, 7-12 Months, Years 1,2,3 |
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| Secondary | Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye | All participants with data available. | Posted | Number | percentage of participants | UP to 4 Years |
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Up to 4 Years |
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|
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| Secondary | Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye | All participants with data available. | Posted | Number | percentage of participants | 4 Years |
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| Secondary | Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye | All participants with data available. | Posted | Number | percentage of participants | 4 Years |
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Baseline, Up to 4 Years |
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| 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. | All participants with data available. | Posted | Number | percentage of participants | Baseline, Up to 4 Years |
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| 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). | All participants with data available. | Posted | Number | percentage of participants | Baseline, Up to 4 Years |
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| Secondary | Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye | All participants with data available. | Posted | Number | percentage of participants | 4 Years |
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| Secondary | Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye | All participants with data available. | Posted | Number | percentage of participants | 4 Years |
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| Secondary | Percentage of Phakic Patients With Cataract Surgery in the Study Eye | Phakic patients have intraocular lens implants. | All phakic participants with data available. | Posted | Number | percentage of participants | 4 Years |
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|
| 12 |
| 165 |
| 0 |
| 165 |
| EG001 | 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. | 12 | 156 | 0 | 156 |
| Hospitalized for sepsis | Infections and infestations | Systematic Assessment |
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| Pacemaker placed | Surgical and medical procedures | Systematic Assessment |
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| Patient was hospitalized for dizziness | Nervous system disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Soft tissue mass cancer right leg | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
|
| Unknown heart complications | Cardiac disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fluid in lungs | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hositalized for heart problems | Cardiac disorders | Systematic Assessment |
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| Hospitalized for lack of oxygen | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyperallergic reaction to iron | Immune system disorders | Systematic Assessment |
|
| Methicilin-resistant staphylococcus aureus | Infections and infestations | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Retinal detachment OS (left eye) | Eye disorders | Systematic Assessment |
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| Spots of blurred vision in left eye | Eye disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Up to Time of Injection 4 (n=145,129) |
|
| Up to Time of Injection 5 (n=137,106) |
|
| Up to Time of Injection 6 (n=115,83) |
|
| Up to Time of Injection 7 (n=104,80) |
|
| Up to Time of Injection 8 (n=85,61) |
|
| Up to Time of Injection 9 (n=74,47) |
|
| Up to Time of Injection 10(n=74,43) |
|
| Up to Time of Injection 11(n=58,25) |
|
| Up to Time of Injection 4(n=158,144) |
|
| Up to Time of Injection 5 (n=148,124) |
|
| Up to Time of Injection 6 (n=129,107) |
|
| Up to Time of Injection 7 (n=115,89) |
|
| Up to Time of Injection 8 (n=94,66) |
|
| Up to Time of Injection 9 (n=84,51) |
|
| Up to Time of Injection 10 (n=76,46) |
|
| Up to Time of Injection 11 (n=61,30) |
|
| Up to Time of Injection 3 (n=141,135) |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Change from Baseline Up to Injection 3 (n=115,117) |
|
| Change from Baseline Up to Injection 4 (n=118,109) |
|
| Change from Baseline Up to Injection 5 (n=109,98) |
|
| Change from Baseline Up to Injection 6 (n=101,86) |
|
| Change from Baseline Up to Injection 7 (n=89,69) |
|
| Change from Baseline Up to Injection 8 (n=73,43) |
|
| Change from Baseline Up to Injection 9 (n=66,37) |
|
| Change from Baseline Up to Injection 10 (n=58,33) |
|
| Change from Baseline Up to Injection 11 (n=49,17) |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Change from Baseline Up to Injection 3 (n=110,95) |
|
| Change from Baseline Up to Injection4 (n=117,104) |
|
| Change from Baseline Up to Injection 5 (n=109,84) |
|
| Change from Baseline Up to Injection 6 (n=93,68) |
|
| Change from Baseline Up to Injection 7 (n=85,67) |
|
| Change from Baseline Up to Injection 8 (n=70,47) |
|
| Change from Baseline Up to Injection 9 (n=63,37) |
|
| Change from Baseline Up to Injection 10 (n=65,31) |
|
| Change from Baseline Up to Injection 11 (n=48,18) |
|
| Up to Time of Injection 4 (n=157,141) |
|
| Up to Time of Injection 5 (n=143,124) |
|
| Up to Time of Injection 6 (n=127,106) |
|
| Up to Time of Injection 7 (n=114,89) |
|
| Up to Time of Injection 8 (n=99,64) |
|
| Up to Time of Injection 9 (n=82,52) |
|
| Up to Time of Injection 10 (n=73,40) |
|
| Up to Time of Injection 11 (n=63,30) |
|
| Year 1 (n = 117,80) |
|
| Year 2 (n = 40,23) |
|
| Year 3 (n = 17,10) |
|
| aflibercept to bevacizumab |
|
| aflibercept to ranibizumab |
|
| ranibizumab to bevacizumab |
|
| ranibizumab to aflibercept |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|
| Up to Time of Injection 4 (n=141,129) |
|
| Up to Time of Injection 5 (n=134,113) |
|
| Up to Time of Injection 6 (n=120,101) |
|
| Up to Time of Injection 7 (n=107,79) |
|
| Up to Time of Injection 8 (n=86,53) |
|
| Up to Time of Injection 9 (n=74,45) |
|
| Up to Time of Injection 10 (n=65,39) |
|
| Up to Time of Injection 11 (n=56,23) |
|