Diabetic RetinopathyAPOLLONNCT02924311
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
An observational study of Diabetic Retinopathy, run by Bayer at 1 site in France.
Trial summary
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 402 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2016to 6 Dec 2019
- 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: Treatment naïve and previously treated diabetic macular disease patients initiating a treatment with intravitreal aflibercept. The prescription of the medicines is clearly separated from the decision to include the patient in the study
Who may be able to join
- Man or woman aged 18 years or older
- Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
- Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
- Patient diagnosed with type 1 or 2 diabetes mellitus
- Patient who has been given appropriate information about the study and who has given his/her written, informed consent
Who cannot join
- Patient with other retinal disease at the time of inclusion
- Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
- Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
- Patient taking part in an interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).
This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
- Conditions
- Diabetic Retinopathy
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Diabetic Macular Edema
- Medical subject headings
- Diabetic Retinopathy
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
Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.
| Study group | Role | What they receive |
|---|---|---|
| Previously treated patient | Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | |
| Naïve patient | Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | |
| Entire study population | Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept 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.
Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients
Measured: At baseline and 12 months
Secondary outcomes (27)
Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population
Measured: At baseline and 12 months
Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups
Measured: At baseline and 24 months
Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups
Measured: At baseline and 12 months
Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups
Measured: At baseline and 24 months
Type of the previous treatment(s) in previously treated patients
i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids
Measured: At baseline
Duration (months) of the previous treatment in previously treated patients
Measured: At baseline
Date of the last administered treatment in previously treated patients
Measured: At baseline
Reason for starting intravitreal aflibercept
i.e: clinically significant macular edema conducting to a decrease of visual acuity, early care of DME, laser photocoagulation or vitrectomy not indicated, diabetes care not optimized
Measured: At baseline, 12 months and 24 months
Number of eyes injected
Measured: Up to 24 months
Number of visits with injection
Measured: Up to 24 months
Interval (days) between injections
Measured: Up to 24 months
Type of adjunctive therapy post IVT aflibercept initiation
i.e: surgery, focal laser, steroids, etc
Measured: Up to 24 months
Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups
Measured: At baseline and 24 months
Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups
Measured: At baseline and 24 months
Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up
Measured: At baseline, 12 months and 24 months
Mean change in HbA1c level during macular disease monitoring
HbA1c: Glycated haemoglobin A1c
Measured: At baseline, 12 months and 24 months
Mean change in blood pressure during macular disease monitoring
Measured: At baseline, 12 months and 24 months
Duration of the disease (DME Monitoring)
Measured: At baseline
Number of visits for monitoring only (DME Monitoring)
Measured: Up to 24 months
Number of visits for injection only (DME Monitoring)
Measured: Up to 24 months
Number of visits combining monitoring and injection (DME Monitoring)
Measured: Up to 24 months
Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)
Monitoring visits for diabetes by diabetologists or general practitioners outside the study center
Measured: Up to 24 months
Number of visits with OCT assessments (DME monitoring)
Measured: Up to 24 months
Number of visits with fundus photography assessments (DME monitoring)
Measured: Up to 24 months
Number of visits with fluorescein angiography assessments (DME monitoring)
Measured: Up to 24 months
Number of visits with visual acuity measurements (DME monitoring)
Measured: Up to 24 months
Number of participants with ocular and non-ocular safety events
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start21 Sep 2016
- Primary completion12 Aug 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 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
- NCT02924311
- Sponsor's protocol ID
- 18636
- Acronym
- APOLLON
- Status last verified
- Nov 2023
- First submitted
- 5 Sep 2016
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1.
PubMed 36309572
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept
- ClinicalTrials.gov ID
- NCT02924311
- Acronym / sponsor ID
- APOLLON / 18636
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 5 Oct 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 main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).
This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previously treated patient | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept |
| Naïve patient | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept |
| Entire study population | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naïve and previously treated diabetic macular disease patients initiating a treatment with intravitreal aflibercept. The prescription of the medicines is clearly separated from the decision to include the patient in the study
Key inclusion criteria (5 listed)
- Man or woman aged 18 years or older
- Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
- Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
- Patient diagnosed with type 1 or 2 diabetes mellitus
- Patient who has been given appropriate information about the study and who has given his/her written, informed consent
Key exclusion criteria (4 listed)
- Patient with other retinal disease at the time of inclusion
- Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
- Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
- Patient taking part in an interventional study
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)Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results. | Drug | Entire study population, Naïve patient, Previously treated patient |
Primary outcome
Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients
Time frame: At baseline and 12 months
27 secondary outcomes
Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population
Time frame: At baseline and 12 months
Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups
Time frame: At baseline and 24 months
Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups
Time frame: At baseline and 12 months
Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups
Time frame: At baseline and 24 months
Type of the previous treatment(s) in previously treated patients
Time frame: At baseline
Duration (months) of the previous treatment in previously treated patients
Time frame: At baseline
Date of the last administered treatment in previously treated patients
Time frame: At baseline
Reason for starting intravitreal aflibercept
Time frame: At baseline, 12 months and 24 months
Number of eyes injected
Time frame: Up to 24 months
Number of visits with injection
Time frame: Up to 24 months
Interval (days) between injections
Time frame: Up to 24 months
Type of adjunctive therapy post IVT aflibercept initiation
Time frame: Up to 24 months
Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups
Time frame: At baseline and 24 months
Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups
Time frame: At baseline and 24 months
Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up
Time frame: At baseline, 12 months and 24 months
Mean change in HbA1c level during macular disease monitoring
Time frame: At baseline, 12 months and 24 months
Mean change in blood pressure during macular disease monitoring
Time frame: At baseline, 12 months and 24 months
Duration of the disease (DME Monitoring)
Time frame: At baseline
Number of visits for monitoring only (DME Monitoring)
Time frame: Up to 24 months
Number of visits for injection only (DME Monitoring)
Time frame: Up to 24 months
Number of visits combining monitoring and injection (DME Monitoring)
Time frame: Up to 24 months
Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)
Time frame: Up to 24 months
Number of visits with OCT assessments (DME monitoring)
Time frame: Up to 24 months
Number of visits with fundus photography assessments (DME monitoring)
Time frame: Up to 24 months
Number of visits with fluorescein angiography assessments (DME monitoring)
Time frame: Up to 24 months
Number of visits with visual acuity measurements (DME monitoring)
Time frame: Up to 24 months
Number of participants with ocular and non-ocular safety events
Time frame: Up to 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 7 Nov 2023.
- Results publication: PubMed 36309572Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1.
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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 Diabetic Retinopathy, 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 5 inclusion and 4 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 7 Nov 2023. 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?
Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients (time frame: At baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924311, which also lists 1 linked publication.
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 7 Nov 2023.