Retinal Vein OcclusionNCT01918371

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

An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Retinal Vein Occlusion, Macular Edema
What is being tested?: Anti-VEGF
Type of treatment: Injection or infusion
How many people: 323 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2013to 4 Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Received Anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME)

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
San Antonio, Texas

Other trials in United States

About this study

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
Being tested: Anti-VEGF
Medical subject headings: Retinal Vein Occlusion, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-VEGFDrug
Also called Avastin®, Lucentis®, Eylea®
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.

Study groups in NCT01918371
Study group	Role	What they receive
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. Receives: Drug: Anti-VEGF
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. Receives: Drug: Anti-VEGF

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Time of Injection 11 (Up to 4 Years)

Secondary outcomes (25)

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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 Years
Time Between Anti-VEGF Injections in the Study Eye
The mean time in months between anti-VEGF Injections.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 4 Years
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
Measured: 4 Years
Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Up to 4 Years
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
Measured: 4 Years
Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
Measured: 4 Years
Percentage of Phakic Patients With Cataract Surgery in the Study Eye
Phakic patients have intraocular lens implants.
Measured: 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20134 Sep 2014

First posted7 Aug 2013 (estimated)
Study start2 Aug 2013
Primary completion4 Sep 2014
Study completion4 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01918371
Sponsor's protocol ID: GMA-OZU-13-598
Status last verified: Apr 2019
First submitted: 5 Aug 2013
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jumper JM, Dugel PU, Chen S, Blinder KJ, Walt JG. Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2). Clin Ophthalmol. 2018 Apr 3;12:621-629. doi: 10.2147/OPTH.S163859. eCollection 2018.
PubMed 29662298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Retinal Vein Occlusion (RVO)

All Retinal Vein Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema
ClinicalTrials.gov ID: NCT01918371
Acronym / sponsor ID: GMA-OZU-13-598
Conditions: Retinal Vein Occlusion, Macular Edema
Study type: Observational
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 2 Aug 2013 (actual)
Primary completion: 4 Sep 2014 (actual)
Study completion: 4 Sep 2014 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 26 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Patients with RVO	–	Drug: Anti-VEGFPatients 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	–	Drug: Anti-VEGFPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Received Anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME)

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti-VEGFAlso: Avastin®, Lucentis®, Eylea®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.	Drug	Patients with DME, Patients with RVO

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

25 secondary outcomes

Percentage of Participants With BCVA of 20/40 or Better in the Study Eye
Time frame: 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
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
Mean BCVA in the Study Eye
Time frame: UP to 4 Years
Change From Baseline in BCVA in the Study Eye
Time frame: 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
Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye
Time frame: Baseline, Up to 4 Years
Change From Baseline in CRT by OCT in the Study Eye
Time frame: Baseline, Up to 4 Years
Time to Improvement of ≥2 Lines in BCVA in the Study Eye
Time frame: 4 Years
Time to Improvement of ≥3 Lines in BCVA in the Study Eye
Time frame: 4 Years
Time to Improvement in BCVA to 20/40 or Better in the Study Eye
Time frame: 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
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
Time Between Anti-VEGF Injections in the Study Eye
Time frame: 4 Years
Number of Intravitreal Anti-VEGF Injections in the Study Eye
Time frame: 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
Time frame: UP to 4 Years
Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
Time frame: Up to 4 Years
Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
Time frame: 4 Years
Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
Time frame: 4 Years
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
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
Percentage of Participants With No Change in BCVA From Baseline in the Study Eye
Time frame: Baseline, Up to 4 Years
Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
Time frame: 4 Years
Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
Time frame: 4 Years
Percentage of Phakic Patients With Cataract Surgery in the Study Eye
Time frame: 4 Years

Results and safety

Results posted to the registry on 26 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With RVO	166	165
Patients With DME	157	156

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Patients With RVO n = 115	Patients With DME n = 104
Value	26.09	16.35

Population analysed: All participants with data available up to time of Injection 2.

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Patients With RVO n = 118	Patients With DME n = 110
Value	28.81	16.36

Population analysed: All participants with data available up to time of Injection 3.

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Patients With RVO n = 128	Patients With DME n = 114
Value	26.56	17.54

Population analysed: All participants with data available up to time of Injection 4.

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Patients With RVO n = 123	Patients With DME n = 95
Value	36.59	22.11

Population analysed: All participants with data available up to time of Injection 5.

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With RVO	12 of 165 (7.3%)	0 of 165 (0%)	Not reported
Patients With DME	12 of 156 (7.7%)	0 of 156 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29662298Jumper JM, Dugel PU, Chen S, Blinder KJ, Walt JG. Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2). Clin Ophthalmol. 2018 Apr 3;12:621-629. doi: 10.2147/OPTH.S163859. eCollection 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Vein Occlusion and Macular Edema, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01918371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.