A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).

Conditions
-----------------
Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
-----------------
* Drug: Anti-VEGF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular edema in the study eye due to RVO or DME Received an anti-VEGF injection in the study eye on or after June 2010 for RVO and on or after August 2012 for DME Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with RVO<br>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. | Drug: Anti-VEGF<br>* 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.<br>* Other names: Eylea®;|
| Patients with DME<br>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. | Drug: Anti-VEGF<br>* 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.<br>* Other names: Eylea®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |