- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01918371
A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema
April 9, 2019 updated by: Allergan
This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
323
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Received Anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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.
Other Names:
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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.
|
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.
Other Names:
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
Up to 4 Years
|
Mean BCVA in the Study Eye
Time Frame: 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).
|
UP to 4 Years
|
Change From Baseline in BCVA in the Study Eye
Time Frame: 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.
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Baseline, Up to 4 Years
|
Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye
Time Frame: 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.
|
Baseline, Up to 4 Years
|
Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye
Time Frame: 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.
|
Baseline, Up to 4 Years
|
Change From Baseline in CRT by OCT in the Study Eye
Time Frame: 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.
|
Baseline, Up to 4 Years
|
Time to Improvement of ≥2 Lines in BCVA in the Study Eye
Time Frame: 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).
|
4 Years
|
Time to Improvement of ≥3 Lines in BCVA in the Study Eye
Time Frame: 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).
|
4 Years
|
Time to Improvement in BCVA to 20/40 or Better in the Study Eye
Time Frame: 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.
|
4 Years
|
Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
Time Frame: 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.
|
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
Time Frame: 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.
|
4 Years
|
Time Between Anti-VEGF Injections in the Study Eye
Time Frame: 4 Years
|
The mean time in months between anti-VEGF Injections.
|
4 Years
|
Number of Intravitreal Anti-VEGF Injections in the Study Eye
Time Frame: 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.
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0-6 Months, 7-12 Months, Years 1,2,3
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Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye
Time Frame: UP to 4 Years
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UP to 4 Years
|
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Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
Time Frame: Up to 4 Years
|
Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.
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Up to 4 Years
|
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
Time Frame: 4 Years
|
4 Years
|
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Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
Time Frame: 4 Years
|
4 Years
|
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Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye
Time Frame: 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.
|
Baseline, Up to 4 Years
|
Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye
Time Frame: 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.
|
Baseline, Up to 4 Years
|
Percentage of Participants With No Change in BCVA From Baseline in the Study Eye
Time Frame: 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).
|
Baseline, Up to 4 Years
|
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
Time Frame: 4 Years
|
4 Years
|
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Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
Time Frame: 4 Years
|
4 Years
|
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Percentage of Phakic Patients With Cataract Surgery in the Study Eye
Time Frame: 4 Years
|
Phakic patients have intraocular lens implants.
|
4 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2013
Primary Completion (Actual)
September 4, 2014
Study Completion (Actual)
September 4, 2014
Study Registration Dates
First Submitted
August 5, 2013
First Submitted That Met QC Criteria
August 5, 2013
First Posted (Estimate)
August 7, 2013
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Edema
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- GMA-OZU-13-598
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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