Study for Collection of Aflibercept Data in Routine Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Eye Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

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

Intervention Type DRUG

Administration by intravitreal injection

Interventions

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

Administration by intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No