Study for Collection of Aflibercept Data in Routine Practice

Study Overview
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Brief Summary
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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
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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.

Official Title
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CODEX:Collection of Aflibercept Data in Routine Practice

Conditions
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Eye Diseases

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY86-5321<br>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) | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Administration by intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Database, Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), Retinal Diseases, Optic Nerve Diseases, Corneal Diseases, Vision Disorders