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

Bayer

Status: Completed

Conditions: Eye Diseases

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02811692

DBOX 2014/00498 (Other Identifier)

17867

Details and patient eligibility

About

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.

Full 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.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

425 participants in 1 patient group

BAY86-5321

Description:

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)

Treatment:

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