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

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918371
• Other study ID #: GMA-OZU-13-598
• Status: Completed
• Start date: August 2, 2013
• Est. completion date: September 4, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: September 4, 2014
• Est. primary completion date: September 4, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Anti-VEGF
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Time of Injection 2 (Up to 4 Years)
Primary	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.	Up to Time of Injection 3 (Up to 4 Years)
Primary	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.	Up to Time of Injection 4 (Up to 4 Years)
Primary	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.	Up to Time of Injection 5 (Up to 4 Years)
Primary	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.	Up to Time of Injection 6 (Up to 4 Years)
Primary	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.	Up to Time of Injection 7 (Up to 4 Years)
Primary	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.	Up to Time of Injection 8 (Up to 4 Years)
Primary	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.	Up to Time of Injection 9 (Up to 4 Years)
Primary	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.	Up to Time of Injection 10 (Up to 4 Years)
Primary	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.	Up to Time of Injection 11 (Up to 4 Years)
Secondary	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	Up to 4 Years
Secondary	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.	Up to 4 Years
Secondary	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.	Up to 4 Years
Secondary	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).	UP to 4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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).	4 Years
Secondary	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).	4 Years
Secondary	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.	4 Years
Secondary	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.	4 Years
Secondary	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.	4 Years
Secondary	Time Between Anti-VEGF Injections in the Study Eye	The mean time in months between anti-VEGF Injections.	4 Years
Secondary	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.	0-6 Months, 7-12 Months, Years 1,2,3
Secondary	Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye		UP to 4 Years
Secondary	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.	Up to 4 Years
Secondary	Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye		4 Years
Secondary	Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye		4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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.	Baseline, Up to 4 Years
Secondary	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).	Baseline, Up to 4 Years
Secondary	Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye		4 Years
Secondary	Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye		4 Years
Secondary	Percentage of Phakic Patients With Cataract Surgery in the Study Eye	Phakic patients have intraocular lens implants.	4 Years