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| ID | Type | Description | Link |
|---|---|---|---|
| DBOX 2014/00498 | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Administration by intravitreal injection |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Adult naïve patients (not previously treated with an anti-VEGF agent) with diagnosis of wet Age-related Macular Degeneration (wAMD), macular edema following Branch Retinal Vein Occlusion (BRVO), macular edema following central retinal vein occlusion (CRVO), and Diabetic Macular Edema (DME) and starting treatment with Aflibercept.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | France |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D009901 | Optic Nerve Diseases |
| D003316 | Corneal Diseases |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |