Trial Condition(s):
Eye Diseases
Study for collection of Aflibercept data in Routine Practice (CODEX)
Bayer Identifier:
17867
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
Primary Outcome
- Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.Timeframe: Baseline and 12 months
- Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).Timeframe: Baseline and 12 months
Secondary Outcome
- Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.in each indicationTimeframe: Baseline and 6 month, 18 month and 24 month
- Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).in each indicationTimeframe: Baseline and 6 month, 18 month and 24 month
- Number of injectionsin each indicationTimeframe: Baseline and 6 month, 12 month, 18 month and 24 months
- Interval (days) between injections per diseasein each indicationTimeframe: 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) populationTimeframe: 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)Timeframe: Baseline and 6 month, 12 month, 18 month and 24 months
- Type of adjunctive therapies (ie focal laser, steroids etc.)Timeframe: Baseline and 6 month, 12 month, 18 month and 24 months
- Change in score of diabetic retinopathy as determined by treating ophthalmologistIn Diabetic Macular Edema (DME) populationTimeframe: Baseline and 6 month, 12 month, 18 month and 24 months
Additional Information
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