CODEX: Study for Collection of Aflibercept Data in Routine Practice

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02811692

Collaborator

Regeneron Pharmaceuticals (Industry)

425

Enrollment

Location

13.9

Actual Duration (Months)

30.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

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.

Study Design

Study Type:

Observational

Actual Enrollment :

425 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

CODEX:Collection of Aflibercept Data in Routine Practice

Actual Study Start Date :

Sep 30, 2016

Actual Primary Completion Date :

Nov 27, 2017

Actual Study Completion Date :

Nov 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
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)	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Administration by intravitreal injection

Arm

Intervention/Treatment

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)

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Administration by intravitreal injection

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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 [Baseline and 6 month, 12 month, 18 month and 24 months]
In Diabetic Macular Edema (DME) population

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.