NCT02811692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

June 21, 2016

Last Update Submit

July 1, 2019

Conditions

Eye Diseases

Keywords

DatabaseDiabetic Macular Edema (DME)Wet Age-related Macular Degeneration (wAMD)Retinal DiseasesOptic Nerve DiseasesCorneal DiseasesVision Disorders

Outcome Measures

Primary Outcomes (2)

  • Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.

    Baseline and 12 months

  • Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).

    Baseline and 12 months

Secondary Outcomes (8)

  • Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.

    Baseline and 6 month, 18 month and 24 month

  • Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).

    Baseline and 6 month, 18 month and 24 month

  • Number of injections

    Baseline and 6 month, 12 month, 18 month and 24 months

  • Interval (days) between injections per disease

    Baseline and 6 month, 12 month, 18 month and 24 months

  • Presence of pigment epithelial detachment (PED) (Y/N)

    Baseline and 6 month, 12 month, 18 month and 24 months

  • +3 more secondary outcomes

Study Arms (1)

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)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)DRUG

Administration by intravitreal injection

BAY86-5321

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, France

Location

Related Links

MeSH Terms

Conditions

Eye DiseasesRetinal DiseasesOptic Nerve DiseasesCorneal DiseasesVision Disorders

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

September 30, 2016

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

FR(1)