Eye Diseases
Conditions
Keywords
Database, Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), Retinal Diseases, Optic Nerve Diseases, Corneal Diseases, Vision Disorders
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.
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of injections | Baseline and 6 month, 12 month, 18 month and 24 months | in each indication |
| Interval (days) between injections per disease | 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 |
| 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 |
| 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 | Baseline and 6 month, 12 month, 18 month and 24 months | In Diabetic Macular Edema (DME) population |
| 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 Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT). | Baseline and 6 month, 18 month and 24 month | in each indication |
Countries
France
Outcome results
None listed