Study for Collection of Aflibercept Data in Routine Practice

Eye Diseases Clinical Trial

— CODEX  

Official title:

CODEX:Collection of Aflibercept Data in Routine Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811692
• Other study ID #: 17867
• Secondary ID: DBOX 2014/00498
• Status: Completed
• Start date: September 30, 2016
• Est. completion date: November 27, 2017

Study information

• Verified date: June 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.		Baseline and 12 months
Primary	Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).		Baseline and 12 months
Secondary	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
Secondary	Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).	in each indication	Baseline and 6 month, 18 month and 24 month
Secondary	Number of injections	in each indication	Baseline and 6 month, 12 month, 18 month and 24 months
Secondary	Interval (days) between injections per disease	in each indication	Baseline and 6 month, 12 month, 18 month and 24 months
Secondary	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
Secondary	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
Secondary	Type of adjunctive therapies (ie focal laser, steroids etc.)		Baseline and 6 month, 12 month, 18 month and 24 months
Secondary	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

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