Trial Outcomes & Findings for A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema (NCT NCT01918371)
NCT ID: NCT01918371
Last Updated: 2019-04-18
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
323 participants
Primary outcome timeframe
Up to Time of Injection 2 (Up to 4 Years)
Results posted on
2019-04-18
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
157
|
|
Overall Study
Participants With Complete Data
|
165
|
156
|
|
Overall Study
COMPLETED
|
165
|
156
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Missing Data
|
1
|
1
|
Baseline Characteristics
A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
FULL_RANGE 13.62 • n=5 Participants
|
63.4 years
FULL_RANGE 11.29 • n=7 Participants
|
66.4 years
FULL_RANGE NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 2 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=115 Participants
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
n=104 Participants
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.
|
|---|---|---|
|
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
|
16.35 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 3 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=118 Participants
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
n=110 Participants
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.
|
|---|---|---|
|
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
|
16.36 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 4 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=128 Participants
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
n=114 Participants
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.
|
|---|---|---|
|
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
|
17.54 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 5 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=123 Participants
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
n=95 Participants
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.
|
|---|---|---|
|
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
|
22.11 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 6 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=106 Participants
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
n=77 Participants
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.
|
|---|---|---|
|
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
|
19.48 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 7 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=96 Participants
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
n=70 Participants
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.
|
|---|---|---|
|
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
|
20.00 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 8 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=77 Participants
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
n=48 Participants
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.
|
|---|---|---|
|
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
|
18.75 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 9 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=64 Participants
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
n=41 Participants
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.
|
|---|---|---|
|
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
|
24.39 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 10 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=63 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
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
|
22.22 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Time of Injection 11 (Up to 4 Years)Population: All participants with data available up to time of 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.
Outcome measures
| Measure |
Patients With RVO
n=53 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
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
|
38.89 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 YearsPopulation: All participants with data available.
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
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
54.89 percentage of participants
|
|
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
|
53.33 percentage of participants
|
|
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
|
51.94 percentage of participants
|
|
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
|
56.64 percentage of participants
|
|
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
|
55.45 percentage of participants
|
|
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
|
54.43 percentage of participants
|
|
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
|
62.26 percentage of participants
|
|
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
|
55.56 percentage of participants
|
|
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
|
53.85 percentage of participants
|
|
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
|
56.52 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
28.81 percentage of participants
|
|
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
|
26.23 percentage of participants
|
|
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
|
29.46 percentage of participants
|
|
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
|
33.02 percentage of participants
|
|
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
|
33.73 percentage of participants
|
|
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
|
31.25 percentage of participants
|
|
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
|
27.87 percentage of participants
|
|
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
|
31.91 percentage of participants
|
|
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
|
27.91 percentage of participants
|
|
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
|
48.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
59.86 percentage of participants
|
|
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
|
57.82 percentage of participants
|
|
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
|
58.33 percentage of participants
|
|
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
|
62.10 percentage of participants
|
|
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
|
63.55 percentage of participants
|
|
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
|
60.67 percentage of participants
|
|
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
|
60.61 percentage of participants
|
|
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
|
58.82 percentage of participants
|
|
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
|
54.35 percentage of participants
|
|
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
|
60.00 percentage of participants
|
SECONDARY outcome
Timeframe: UP to 4 YearsPopulation: All participants with data available.
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).
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Mean BCVA in the Study Eye
Baseline (n=133,130)
|
10.6 lines
Standard Deviation 4.04
|
11.8 lines
Standard Deviation 3.50
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 2 (n=139,133)
|
12.7 lines
Standard Deviation 3.69
|
12.8 lines
Standard Deviation 3.38
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 3 (n=141,135)
|
13.0 lines
Standard Deviation 3.56
|
12.9 lines
Standard Deviation 2.97
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 4 (n=141,129)
|
12.4 lines
Standard Deviation 4.09
|
12.9 lines
Standard Deviation 3.20
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 5 (n=134,113)
|
12.7 lines
Standard Deviation 3.87
|
13.0 lines
Standard Deviation 3.02
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 6 (n=120,101)
|
12.5 lines
Standard Deviation 3.82
|
12.9 lines
Standard Deviation 2.89
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 7 (n=107,79)
|
12.5 lines
Standard Deviation 3.97
|
12.8 lines
Standard Deviation 3.18
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 8 (n=86,53)
|
12.3 lines
Standard Deviation 4.12
|
12.8 lines
Standard Deviation 3.37
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 9 (n=74,45)
|
12.7 lines
Standard Deviation 3.80
|
12.7 lines
Standard Deviation 3.52
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 10 (n=65,39)
|
12.3 lines
Standard Deviation 3.49
|
12.3 lines
Standard Deviation 3.81
|
|
Mean BCVA in the Study Eye
Up to Time of Injection 11 (n=56,23)
|
12.1 lines
Standard Deviation 3.83
|
12.0 lines
Standard Deviation 4.88
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Change From Baseline in BCVA in the Study Eye
Baseline (n=133,130)
|
10.6 lines
Standard Deviation 4.04
|
11.8 lines
Standard Deviation 3.50
|
|
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
|
1.0 lines
Standard Deviation 2.46
|
|
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
|
1.3 lines
Standard Deviation 2.63
|
|
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
|
1.1 lines
Standard Deviation 2.51
|
|
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
|
1.3 lines
Standard Deviation 2.62
|
|
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
|
1.2 lines
Standard Deviation 2.48
|
|
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
|
1.1 lines
Standard Deviation 2.31
|
|
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
|
0.8 lines
Standard Deviation 2.65
|
|
Change From Baseline in BCVA in the Study Eye
Change from Baseline Up to Injection 9 (n=66,37)
|
1.9 lines
Standard Deviation 4.00
|
1.5 lines
Standard Deviation 3.19
|
|
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
|
1.3 lines
Standard Deviation 3.46
|
|
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
|
0.4 lines
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsBCVA 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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
30.08 percentage of participants
|
|
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
|
35.56 percentage of participants
|
|
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
|
29.46 percentage of participants
|
|
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
|
32.74 percentage of participants
|
|
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
|
25.74 percentage of participants
|
|
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
|
35.44 percentage of participants
|
|
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
|
28.30 percentage of participants
|
|
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
|
33.33 percentage of participants
|
|
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
|
33.33 percentage of participants
|
|
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
|
21.74 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
14.29 percentage of participants
|
|
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
|
20.00 percentage of participants
|
|
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
|
17.83 percentage of participants
|
|
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
|
20.35 percentage of participants
|
|
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
|
19.80 percentage of participants
|
|
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
|
21.52 percentage of participants
|
|
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
|
22.64 percentage of participants
|
|
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
|
28.89 percentage of participants
|
|
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
|
28.21 percentage of participants
|
|
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
|
17.39 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Change From Baseline in CRT by OCT in the Study Eye
Baseline (n=128,119)
|
499.1 µm (microns)
Standard Deviation 188.14
|
413.4 µm (microns)
Standard Deviation 104.85
|
|
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
|
-44.7 µm (microns)
Standard Deviation 93.62
|
|
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
|
-62.1 µm (microns)
Standard Deviation 100.61
|
|
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 204.10
|
-66.8 µm (microns)
Standard Deviation 102.31
|
|
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
|
-55.7 µm (microns)
Standard Deviation 82.23
|
|
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
|
-63.0 µm (microns)
Standard Deviation 89.54
|
|
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
|
-70.1 µm (microns)
Standard Deviation 97.13
|
|
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
|
-82.5 µm (microns)
Standard Deviation 103.79
|
|
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
|
-66.4 µm (microns)
Standard Deviation 108.21
|
|
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
|
-60.9 µm (microns)
Standard Deviation 105.07
|
|
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
|
-76.0 µm (microns)
Standard Deviation 119.54
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with available data.
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).
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Time to Improvement of ≥2 Lines in BCVA in the Study Eye
|
4.6667 months
Interval 0.0 to 44.6333
|
7.1500 months
Interval 0.0 to 45.033
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with available data.
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).
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Time to Improvement of ≥3 Lines in BCVA in the Study Eye
|
7.2167 months
Interval 0.0 to 44.6333
|
9.1000 months
Interval 0.233 to 843.7
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with available data.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Time to Improvement in BCVA to 20/40 or Better in the Study Eye
|
2.3167 months
Interval 0.0667 to 44.6333
|
3.3667 months
Interval 0.0 to 843.7
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with available data.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
|
2.5333 months
Interval 0.2333 to 45.7333
|
7.9333 months
Interval 0.233 to 854.133
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with available data.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
Interval 0.2333 to 45.7333
|
9.8000 months
Interval 0.233 to 854.133
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with data available.
The mean time in months between anti-VEGF Injections.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
1.5 months
Standard Deviation 1.38
|
|
Time Between Anti-VEGF Injections in the Study Eye
Up to Time of Injection 3 (n=162,154)
|
1.1 months
Standard Deviation 0.60
|
1.6 months
Standard Deviation 1.32
|
|
Time Between Anti-VEGF Injections in the Study Eye
Up to Time of Injection 4 (n=157,141)
|
1.4 months
Standard Deviation 1.10
|
1.7 months
Standard Deviation 1.49
|
|
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
|
1.4 months
Standard Deviation 0.97
|
|
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
|
1.3 months
Standard Deviation 0.60
|
|
Time Between Anti-VEGF Injections in the Study Eye
Up to Time of Injection 7 (n=114,89)
|
1.5 months
Standard Deviation 1.70
|
1.5 months
Standard Deviation 1.20
|
|
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
|
1.3 months
Standard Deviation 0.59
|
|
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
|
1.4 months
Standard Deviation 1.12
|
|
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
|
1.2 months
Standard Deviation 0.64
|
|
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
|
1.2 months
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 0-6 Months, 7-12 Months, Years 1,2,3Population: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
0-6 Months (n = 158,149)
|
4.4 injections
Standard Deviation 1.40
|
4.0 injections
Standard Deviation 1.64
|
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
7-12 Months (n = 99,64)
|
3.3 injections
Standard Deviation 1.64
|
2.8 injections
Standard Deviation 1.42
|
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
Year 1 (n = 117,80)
|
7.1 injections
Standard Deviation 2.90
|
5.8 injections
Standard Deviation 2.77
|
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
Year 2 (n = 40,23)
|
5.4 injections
Standard Deviation 2.98
|
5.0 injections
Standard Deviation 2.65
|
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
Year 3 (n = 17,10)
|
5.9 injections
Standard Deviation 2.99
|
3.4 injections
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: UP to 4 YearsPopulation: All participants with data available.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=155 Participants
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.
|
|---|---|---|
|
Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye
|
33.33 percentage of participants
|
47.44 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 YearsPopulation: All participants with data available.
Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
bevacizumab to aflibercept
|
2.67 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
bevacizumab to ranibizumab
|
13.33 percentage of participants
|
25.26 percentage of participants
|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
aflibercept to bevacizumab
|
4.00 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
aflibercept to ranibizumab
|
20.00 percentage of participants
|
1.05 percentage of participants
|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
ranibizumab to bevacizumab
|
53.33 percentage of participants
|
73.68 percentage of participants
|
|
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
ranibizumab to aflibercept
|
6.67 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with data available.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
|
20.00 percentage of participants
|
44.87 percentage of participants
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with data available.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
|
5.45 percentage of participants
|
13.46 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
15.79 percentage of participants
|
|
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
|
21.48 percentage of participants
|
|
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
|
23.26 percentage of participants
|
|
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
|
15.04 percentage of participants
|
|
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
|
19.80 percentage of participants
|
|
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
|
18.99 percentage of participants
|
|
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
|
22.64 percentage of participants
|
|
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
|
17.78 percentage of participants
|
|
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
|
20.51 percentage of participants
|
|
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
|
13.04 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
45.86 percentage of participants
|
|
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
|
53.33 percentage of participants
|
|
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
|
47.29 percentage of participants
|
|
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
|
50.44 percentage of participants
|
|
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
|
44.55 percentage of participants
|
|
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
|
45.57 percentage of participants
|
|
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
|
45.28 percentage of participants
|
|
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
|
44.44 percentage of participants
|
|
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
|
41.03 percentage of participants
|
|
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
|
39.13 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 4 YearsPopulation: All participants with data available.
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).
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
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
|
30.77 percentage of participants
|
|
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
|
21.74 percentage of participants
|
|
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
|
34.59 percentage of participants
|
|
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
|
19.26 percentage of participants
|
|
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
|
25.58 percentage of participants
|
|
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
|
24.78 percentage of participants
|
|
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
|
23.76 percentage of participants
|
|
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
|
30.38 percentage of participants
|
|
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
|
18.87 percentage of participants
|
|
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
|
31.11 percentage of participants
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with data available.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
|
0.61 percentage of participants
|
0.64 percentage of participants
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All participants with data available.
Outcome measures
| Measure |
Patients With RVO
n=165 Participants
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
n=156 Participants
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.
|
|---|---|---|
|
Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
|
1.21 percentage of participants
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: 4 YearsPopulation: All phakic participants with data available.
Phakic patients have intraocular lens implants.
Outcome measures
| Measure |
Patients With RVO
n=117 Participants
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
n=104 Participants
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.
|
|---|---|---|
|
Percentage of Phakic Patients With Cataract Surgery in the Study Eye
|
17.0 percentage of participants
|
15.0 percentage of participants
|
Adverse Events
Patients With RVO
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With DME
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With RVO
n=165 participants at risk
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
n=156 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Infections and infestations
Hospitalized for sepsis
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Surgical and medical procedures
Pacemaker placed
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Nervous system disorders
Patient was hospitalized for dizziness
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue mass cancer right leg
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Nervous system disorders
Stroke
|
0.00%
0/165 • Up to 4 Years
|
0.64%
1/156 • Up to 4 Years
|
|
Nervous system disorders
Transient ischemic attack
|
0.61%
1/165 • Up to 4 Years
|
1.3%
2/156 • Up to 4 Years
|
|
Cardiac disorders
Unknown heart complications
|
0.00%
0/165 • Up to 4 Years
|
1.3%
2/156 • Up to 4 Years
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Respiratory, thoracic and mediastinal disorders
Fluid in lungs
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Cardiac disorders
Hositalized for heart problems
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for lack of oxygen
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Immune system disorders
Hyperallergic reaction to iron
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Infections and infestations
Methicilin-resistant staphylococcus aureus
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Renal and urinary disorders
Renal failure
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Eye disorders
Retinal detachment OS (left eye)
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Eye disorders
Spots of blurred vision in left eye
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
|
Ear and labyrinth disorders
Vertigo
|
0.61%
1/165 • Up to 4 Years
|
0.00%
0/156 • Up to 4 Years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER