Eye DiseasesCODEXNCT02811692
Study for Collection of Aflibercept Data in Routine Practice
An observational study of Eye Diseases, run by Bayer at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 425 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2016to 27 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: CODEX:Collection of Aflibercept Data in Routine Practice
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.
Read the 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.
- Conditions
- Eye Diseases
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Database, Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), Retinal Diseases, Optic Nerve Diseases, Corneal Diseases, Vision Disorders
- Medical subject headings
- Eye Diseases, Retinal Diseases, Optic Nerve Diseases, Corneal Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
Administration by intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
Measured: Baseline and 12 months
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Measured: Baseline and 12 months
Secondary outcomes (8)
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
in each indication
Measured: Baseline and 6 month, 18 month and 24 month
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
in each indication
Measured: Baseline and 6 month, 18 month and 24 month
Number of injections
in each indication
Measured: Baseline and 6 month, 12 month, 18 month and 24 months
Interval (days) between injections per disease
in each indication
Measured: 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) population
Measured: 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)
Measured: Baseline and 6 month, 12 month, 18 month and 24 months
Type of adjunctive therapies (ie focal laser, steroids etc.)
Measured: Baseline and 6 month, 12 month, 18 month and 24 months
Change in score of diabetic retinopathy as determined by treating ophthalmologist
In Diabetic Macular Edema (DME) population
Measured: Baseline and 6 month, 12 month, 18 month and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start30 Sep 2016
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811692
- Sponsor's protocol ID
- 17867
- Other IDs
- DBOX 2014/00498
- Acronym
- CODEX
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2016
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CODEX:Collection of Aflibercept Data in Routine Practice
- ClinicalTrials.gov ID
- NCT02811692
- Acronym / sponsor ID
- CODEX / 17867
- Conditions
- Eye Diseases
- Keywords
- Database, Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), Retinal Diseases, Optic Nerve Diseases, Corneal Diseases, Vision Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY86-5321 | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Who have any contraindications listed in the EYLEA Summary of Product characteristics
- Participating in an investigational program with interventions outside of routine clinical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Administration by intravitreal injection | Drug | BAY86-5321 |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
Time frame: Baseline and 12 months
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Time frame: Baseline and 12 months
8 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.
Time frame: Baseline and 6 month, 18 month and 24 month
Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).
Time frame: Baseline and 6 month, 18 month and 24 month
Number of injections
Time frame: Baseline and 6 month, 12 month, 18 month and 24 months
Interval (days) between injections per disease
Time frame: Baseline and 6 month, 12 month, 18 month and 24 months
Presence of pigment epithelial detachment (PED) (Y/N)
Time frame: 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)
Time frame: Baseline and 6 month, 12 month, 18 month and 24 months
Type of adjunctive therapies (ie focal laser, steroids etc.)
Time frame: Baseline and 6 month, 12 month, 18 month and 24 months
Change in score of diabetic retinopathy as determined by treating ophthalmologist
Time frame: Baseline and 6 month, 12 month, 18 month and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Bayer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS. (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.