Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion (RETRO CRVO)

September 4, 2018 updated by: Bayer

RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

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

  • Belgium
      • Multiple Locations, Belgium

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

The source population of this study is patients who suffer from visual impairment due to macular edema secondary to central retinal vein occlusion.

Description

Inclusion Criteria:

  • Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
  • Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015

Exclusion Criteria:

  • Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
The source population of this study is patients who suffer from visual impairment due to ME secondary to CRVO. In order to ensure the representativeness of the study population, the number of Belgian patients which started Eylea treatment during the brief period between the 1st of June 2014 and the 28th of February 2015 were taken into account. However, data of patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.
Drug: Aflibercept (Eylea, BAY86-5321)

Eylea (intravitreal aflibercept) is an anti-Vascular Endothelial Growth Factor (VEGF) drug indicated for neovascular age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and visual impairment due to macular edema (ME) secondary to central or branched retinal vein occlusion (RVO).

RVO, both branch and central, is the second most common type of retinal vascular disorders after diabetic retinal disease. Central retinal vein occlusion (CRVO) is characterized by an obstruction of the central retinal vein combined with variable amounts of retinal arterial insufficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment duration
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea
Number of eyes treated (mono-and biocular)
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea
Change in visual acuity (BCVA score)
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea
Number of Eylea injections per treated eye
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea
Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment.
Time Frame: At 12 months of treatment with Eylea
At 12 months of treatment with Eylea
Number of patients who discontinued their treatment with Eylea prematurely
Time Frame: At 12 months of treatment with Eylea

Investigator is asked to categorize the number of patients who ended their treatment prematurely according to the following reasons :

  • Lost-to-follow up (measured as number of patients)
  • Lack of efficacy (measured as number of patients)
  • Remission (measured as number of patients)
  • AE (measured as number of patients)
  • Other (measured as number of patients)
At 12 months of treatment with Eylea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

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)

January 21, 2016

Primary Completion (Actual)

December 23, 2017

Study Completion (Actual)

December 23, 2017

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Retinal Vein Occlusion

Clinical Trials on Aflibercept (Eylea, BAY86-5321)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe