Study for Collection of Aflibercept Data in Routine Practice

Completed

• Conditions: Eye Diseases
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02811692
• Lead Sponsor: Bayer

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Study Start: 2016-09-30
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2019-06
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-5321	Aflibercept (Eylea, VEGF Trap-Eye, 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 Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.	Baseline and 12 months
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).	Baseline and 6 month, 18 month and 24 month	in each indication
Number of injections	Baseline and 6 month, 12 month, 18 month and 24 months	in each indication
Presence of pigment epithelial detachment (PED) (Y/N)	Baseline and 6 month, 12 month, 18 month and 24 months	In wet age-related macular degeneration (wAMD) population
Type of adjunctive therapies (ie focal laser, steroids etc.)	Baseline and 6 month, 12 month, 18 month and 24 months
Interval (days) between injections per disease	Baseline and 6 month, 12 month, 18 month and 24 months	in each indication
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)	Baseline and 6 month, 12 month, 18 month and 24 months
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.	Baseline and 6 month, 18 month and 24 month	in each indication
Change in score of diabetic retinopathy as determined by treating ophthalmologist	Baseline and 6 month, 12 month, 18 month and 24 months	In Diabetic Macular Edema (DME) population