Study for Collection of Aflibercept Data in Routine Practice

Bayer425 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

425

Conditions

Eye Diseases

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)DRUG

Administration by intravitreal injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, France

Outcomes

Primary Outcomes

Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.

Time frame: Baseline and 12 months

Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).

Time frame: Baseline and 12 months

Secondary Outcomes

Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.

in each indication

Time frame: 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

Time frame: Baseline and 6 month, 18 month and 24 month

Number of injections

in each indication

Time frame: Baseline and 6 month, 12 month, 18 month and 24 months

Interval (days) between injections per disease

in each indication

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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