NCT01918371

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

Completed Results posted Last updated 18 April 2019

What this trial tests

trial testing Anti-VEGF in Retinal Vein Occlusion in 323 participants. Completed in 4 September 2014.

Timeline

2 August 2013

Primary endpoint
4 September 2014

4 September 2014

Quick facts

Lead sponsor	Allergan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	323
Start date	2 August 2013
Primary completion	4 September 2014
Estimated completion	4 September 2014
Sites	1 location across United States

Drugs / interventions tested

• Anti-VEGF (anti-vegf) — full drug profile →

Conditions studied

• Retinal Vein Occlusion — all drugs for Retinal Vein Occlusion →
• Macular Edema — all drugs for Macular Edema →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Retinal Vein Occlusion or Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	26.09
Patients With DME	16.35

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	28.81
Patients With DME	16.36

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	26.56
Patients With DME	17.54

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	36.59
Patients With DME	22.11

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	25.47
Patients With DME	19.48

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	32.29
Patients With DME	20.00

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	25.97
Patients With DME	18.75

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	32.81
Patients With DME	24.39

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	28.57
Patients With DME	22.22

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 Primary · 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.

Group	Value	95% CI
Patients With RVO	28.30
Patients With DME	38.89

Percentage of Participants With BCVA of 20/40 or Better in the Study Eye Secondary · 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 Time of Injection 2 (n=139,133)

Group	Value	95% CI
Patients With RVO	53.24
Patients With DME	54.89

Up to Time of Injection 3 (n=141,135)

Group	Value	95% CI
Patients With RVO	53.19
Patients With DME	53.33

Up to Time of Injection 4 (n=141,129)

Group	Value	95% CI
Patients With RVO	50.35
Patients With DME	51.94

Up to Time of Injection 5 (n=134,113)

Group	Value	95% CI
Patients With RVO	56.72
Patients With DME	56.64

Up to Time of Injection 6 (n=120,101)

Group	Value	95% CI
Patients With RVO	47.50
Patients With DME	55.45

Up to Time of Injection 7 (n=107,79)

Group	Value	95% CI
Patients With RVO	48.60
Patients With DME	54.43

Up to Time of Injection 8 (n=86,53)

Group	Value	95% CI
Patients With RVO	46.51
Patients With DME	62.26

Up to Time of Injection 9 (n=74,45)

Group	Value	95% CI
Patients With RVO	52.70
Patients With DME	55.56

Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye Secondary · 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 Time of Injection 2 (n=133,118)

Group	Value	95% CI
Patients With RVO	50.38
Patients With DME	28.81

Up to Time of Injection 3 (n=134,122)

Group	Value	95% CI
Patients With RVO	56.72
Patients With DME	26.23

Up to Time of Injection 4 (n=145,129)

Group	Value	95% CI
Patients With RVO	53.10
Patients With DME	29.46

Up to Time of Injection 5 (n=137,106)

Group	Value	95% CI
Patients With RVO	59.12
Patients With DME	33.02

Up to Time of Injection 6 (n=115,83)

Group	Value	95% CI
Patients With RVO	54.78
Patients With DME	33.73

Up to Time of Injection 7 (n=104,80)

Group	Value	95% CI
Patients With RVO	56.73
Patients With DME	31.25

Up to Time of Injection 8 (n=85,61)

Group	Value	95% CI
Patients With RVO	57.65
Patients With DME	27.87

Up to Time of Injection 9 (n=74,47)

Group	Value	95% CI
Patients With RVO	63.51
Patients With DME	31.91

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 4 Years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With RVO

Serious: 12/165 (7%)

Deaths: —

Patients With DME

Serious: 12/156 (8%)

Deaths: —

Serious adverse events (21 terms)

Reaction	System	Patients With RVO	Patients With DME
Transient ischemic attack	Nervous system disorders	—	—
Unknown heart complications	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Hospitalized for sepsis	Infections and infestations	—	—
Pacemaker placed	Surgical and medical procedures	—	—
Patient was hospitalized for dizziness	Nervous system disorders	—	—
Pneumonia	Infections and infestations	—	—
Soft tissue mass cancer right leg	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Stomach pain	Gastrointestinal disorders	—	—
Stroke	Nervous system disorders	—	—
Bowel obstruction	Gastrointestinal disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Fluid in lungs	Respiratory, thoracic and mediastinal disorders	—	—
Hositalized for heart problems	Cardiac disorders	—	—
Hospitalized for lack of oxygen	Respiratory, thoracic and mediastinal disorders	—	—
Hyperallergic reaction to iron	Immune system disorders	—	—
Methicilin-resistant staphylococcus aureus	Infections and infestations	—	—
Renal failure	Renal and urinary disorders	—	—
Retinal detachment OS (left eye)	Eye disorders	—	—
Spots of blurred vision in left eye	Eye disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—

Most-reported serious reactions: Transient ischemic attack, Unknown heart complications, Atrial fibrillation, Hospitalized for sepsis, Pacemaker placed, Patient was hospitalized for dizziness, Pneumonia, Soft tissue mass cancer right leg.

Data from ClinicalTrials.gov NCT01918371 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1).
   Blinder KJ, Dugel PU, Chen S, Jumper JM, et al · · 2017 · cited 100× · PMID 28260851 · DOI 10.2147/opth.s128509
2. Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2).
   Jumper JM, Dugel PU, Chen S, Blinder KJ, et al · · 2018 · cited 44× · PMID 29662298 · DOI 10.2147/opth.s163859