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Completed

NCT Number: NCT01918371

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

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

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-VEGF

Drug

Patients with retinal vein occlusion or diabetic macular edema receiving anti-VEGF injection(s) in accordance with standard of care practices. This is a retrospective chart review study.

Other names: Avastin®, Lucentis®, Eylea®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. Time Between Anti-VEGF Injections in the Study Eye

    Time frame: 4 Years

    The mean time in months between anti-VEGF Injections.

  15. 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.

  16. 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

  17. 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.

  18. Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye

    Time frame: 4 Years

  19. Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye

    Time frame: 4 Years

  20. 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.

  21. 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.

  22. 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).

  23. Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye

    Time frame: 4 Years

  24. Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye

    Time frame: 4 Years

  25. Percentage of Phakic Patients With Cataract Surgery in the Study Eye

    Time frame: 4 Years

    Phakic patients have intraocular lens implants.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2013
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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