check_circleStudy Completed

Eye Diseases

Bayer Identifier:

17867

ClinicalTrials.gov Identifier:

NCT02811692

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study for collection of Aflibercept data in Routine Practice

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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).


  • - Who have any contraindications listed in the EYLEA Summary of Product characteristics
    - Participating in an investigational program with interventions outside of routine clinical practice.

Trial summary

Enrollment Goal
425
Trial Dates
September 2016 - November 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France

Primary Outcome

  • Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
    in each indication
    date_rangeTime Frame:
    Baseline and 6 month, 18 month and 24 month
    enhanced_encryption
    Safety Issue:
    No
  • Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
    in each indication
    date_rangeTime Frame:
    Baseline and 6 month, 18 month and 24 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of injections
    in each indication
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Interval (days) between injections per disease
    in each indication
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Presence of pigment epithelial detachment (PED) (Y/N)
    In wet age-related macular degeneration (wAMD) population
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of adjunctive therapies (ie focal laser, steroids etc.)
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in score of diabetic retinopathy as determined by treating ophthalmologist
    In Diabetic Macular Edema (DME) population
    date_rangeTime Frame:
    Baseline and 6 month, 12 month, 18 month and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

CODEX:Collection of Aflibercept data in Routine Practice
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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