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

Completed

Conditions: Retinal Vein Occlusion
Macular Edema

Interventions: Drug: Anti-VEGF

Registration Number: NCT01918371

Lead Sponsor: Allergan

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 323

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with DME	Anti-VEGF	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.
Patients with RVO	Anti-VEGF	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5	Up to Time of Injection 5 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6	Up to Time of Injection 6 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7	Up to Time of Injection 7 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8	Up to Time of Injection 8 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2	Up to Time of Injection 2 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3	Up to Time of Injection 3 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4	Up to Time of Injection 4 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9	Up to Time of Injection 9 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10	Up to Time of Injection 10 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11	Up to Time of Injection 11 (Up to 4 Years)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.

Secondary Outcome Measures

Name	Time	Method
Percentage of Phakic Patients With Cataract Surgery in the Study Eye	4 Years	Phakic patients have intraocular lens implants.
Percentage of Participants With BCVA of 20/40 or Better in the Study Eye	Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly
Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye	Up to 4 Years	CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye	Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Mean BCVA in the Study Eye	UP to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).
Change From Baseline in BCVA in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A positive change from Baseline indicates improvement.
Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly from Baseline indicates improvement.
Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly from Baseline indicates improvement.
Change From Baseline in CRT by OCT in the Study Eye	Baseline, Up to 4 Years	CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.
Time to Improvement of ≥2 Lines in BCVA in the Study Eye	4 Years	Kaplan-Meier estimates of the time in months to improvement of ≥2 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).
Time to Improvement of ≥3 Lines in BCVA in the Study Eye	4 Years	Kaplan-Meier estimates of the time in months to improvement of ≥3 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).
Time to Improvement in BCVA to 20/40 or Better in the Study Eye	4 Years	Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly.
Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye	4 Years	Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye	4 Years	Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.
Time Between Anti-VEGF Injections in the Study Eye	4 Years	The mean time in months between anti-VEGF Injections.
Number of Intravitreal Anti-VEGF Injections in the Study Eye	0-6 Months, 7-12 Months, Years 1,2,3	To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.
Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye	UP to 4 Years
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye	Up to 4 Years	Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye	4 Years
Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye	4 Years
Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.
Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.
Percentage of Participants With No Change in BCVA From Baseline in the Study Eye	Baseline, Up to 4 Years	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye	4 Years
Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye	4 Years