Study for Collection of Aflibercept Data in Routine Practice (CODEX)

July 1, 2019 updated by: Bayer

CODEX:Collection of Aflibercept Data in Routine Practice

The French CODEX study is designed as a national database to describe, in routine medical practice, functional and anatomical responses to intravitreal Aflibercept injection, in a large population of anti-VGEF-naïve patients presenting with wet Age-related Macular Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather databases from French private and public ophthalmologic centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The retrospective data will be gathered from the first injection of Aflibercept for the indications macular edema following Branch Retinal Vein Occlusion (BRVO) directly by each physician. For each patient, the first injection date of Aflibercept is defined as the index date.

Electronic files from each ophthalmologist, containing patient medical records, will be periodically transmitted according to the milestones of the study with a maximum of 4 transfers (at Q2 2016 for the first transfer and then every 9 months thereafter).

As each electronic transfer will be independent of each other and as patients' data will be anonymized by physicians before each transfer, data comparisons will be not possible between the four electronic files transfers planned over the study period.

Study Type

Observational

Enrollment (Actual)

425

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

  • France
      • Multiple Locations, France

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

Adult naïve patients (not previously treated with an anti-VEGF agent) with diagnosis of wet Age-related Macular Degeneration (wAMD), macular edema following Branch Retinal Vein Occlusion (BRVO), macular edema following central retinal vein occlusion (CRVO), and Diabetic Macular Edema (DME) and starting treatment with Aflibercept.

Description

Inclusion Criteria:

  • Aged ≥18 years old
  • Anti-VEGF (Vascular Endothelial Growth Factor) treatment naïve
  • Intravitreal (IVT) aflibercept injection treatment follows the recommendations made within the EYLEA Summary of Product Characteristics
  • Diagnosed with wAMD (wet Age-related Macular Degeneration), macular edema following CRVO (Central Retinal Vein Occlusion), macular edema following BRVO (Branch Retinal Vein Occlusion), or DME (Diabetic Macular Edema).

Exclusion Criteria:

  • Who have any contraindications listed in the EYLEA Summary of Product characteristics
  • Participating in an investigational program with interventions outside of routine clinical practice.

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
BAY86-5321
Anti-Vascular Endothelial Growth Factor (VEGF) - naive patients starting intravitreal Aflibercept injection treatment for Neovascular age-related macular degeneration (AMD), macular edema following Branch Retinal Vein Occlusion (BRVO), macular edema following central retinal vein occlusion (CRVO), and diabetic macular edema (DME)
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
Time Frame: Baseline and 12 months
Baseline and 12 months
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Time Frame: Baseline and 12 months
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
Time Frame: Baseline and 6 month, 18 month and 24 month
in each indication
Baseline and 6 month, 18 month and 24 month
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Time Frame: Baseline and 6 month, 18 month and 24 month
in each indication
Baseline and 6 month, 18 month and 24 month
Number of injections
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
in each indication
Baseline and 6 month, 12 month, 18 month and 24 months
Interval (days) between injections per disease
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
in each indication
Baseline and 6 month, 12 month, 18 month and 24 months
Presence of pigment epithelial detachment (PED) (Y/N)
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
In wet age-related macular degeneration (wAMD) population
Baseline and 6 month, 12 month, 18 month and 24 months
Proportion of patients with no fluid determined by OCT (absence of fluid includes all types of fluid and location of fluid as determined by the treating ophthalmologist)
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
Baseline and 6 month, 12 month, 18 month and 24 months
Type of adjunctive therapies (ie focal laser, steroids etc.)
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
Baseline and 6 month, 12 month, 18 month and 24 months
Change in score of diabetic retinopathy as determined by treating ophthalmologist
Time Frame: Baseline and 6 month, 12 month, 18 month and 24 months
In Diabetic Macular Edema (DME) population
Baseline and 6 month, 12 month, 18 month and 24 months

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 30, 2016

Primary Completion (Actual)

November 27, 2017

Study Completion (Actual)

November 27, 2017

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17867
  • DBOX 2014/00498 (Other Identifier: Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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