Clinical trial NCT02811692: Study for Collection of Aflibercept Data in Routine Practice
Official title: CODEX:Collection of Aflibercept Data in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Keywords: Database
Diabetic Macular Edema (DME)
Wet Age-related Macular Degeneration (wAMD)
Retinal Diseases
Optic Nerve Diseases
Corneal Diseases
Vision Disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2016-06-23
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
timeFrame: Baseline and 12 months
measure: Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
timeFrame: Baseline and 6 month, 18 month and 24 month
measure: Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
timeFrame: Baseline and 6 month, 18 month and 24 month
measure: Number of injections
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
measure: Interval (days) between injections per disease
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
measure: Presence of pigment epithelial detachment (PED) (Y/N)
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
measure: 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)
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
measure: Type of adjunctive therapies (ie focal laser, steroids etc.)
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
measure: Change in score of diabetic retinopathy as determined by treating ophthalmologist
timeFrame: Baseline and 6 month, 12 month, 18 month and 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: