Study for Collection of Aflibercept Data in Routine Practice

Sponsor
Bayer
Study ID
NCT02811692
Status
Completed

Conditions

  • Eye Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2016
Status verified
Jun 2019
Primary completion
Nov 27, 2017
Completion
Nov 27, 2017

Study Design

Enrollment
425 participants (actual)

Arms

  • Arm: 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)

Primary Outcome Measure

Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS. [ Time Frame: Baseline and 12 months ]

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