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Completed

NCT Number: NCT02811692

Study for 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.

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Key information

Conditions

Eye Diseases Corneal Diseases Cranial Nerve Diseases Nervous System Diseases Neurologic Manifestations Optic Nerve Diseases Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Administration by intravitreal injection

Primary outcomes

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

    Time frame: Baseline and 12 months

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

    Time frame: Baseline and 12 months

Secondary outcomes

  1. 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

  2. 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

  3. Number of injections

    Time frame: Baseline and 6 month, 12 month, 18 month and 24 months

    in each indication

  4. Interval (days) between injections per disease

    Time frame: Baseline and 6 month, 12 month, 18 month and 24 months

    in each indication

  5. 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

  6. 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

  7. Type of adjunctive therapies (ie focal laser, steroids etc.)

    Time frame: Baseline and 6 month, 12 month, 18 month and 24 months

  8. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

CODEX:Collection of Aflibercept Data in Routine Practice

Acronym: CODEX

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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