NCT02811692

Study for Collection of Aflibercept Data in Routine Practice

CODEX:Collection of Aflibercept Data in Routine Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 425 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Eye Diseases

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Administration by intravitreal injection

Timeline

• Start date: 2016-09-30
• Primary completion: 2017-11-27
• Completion: 2017-11-27
• First posted: 2016-06-23
• Last updated: 2019-07-02

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study