Macular EdemaNCT02425501
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
An observational study of Macular Edema, run by Bayer at 1 site in Japan.
Trial summary
The objectives of this study are to investigate the safety and effectiveness of EYLEA Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 646 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jan 2015to 13 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female and male patients with DME diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.
Who may be able to join
- Patients who start EYLEA treatment for Diabetic Macular Edema (DME)
Who cannot join
- Patients who have already received EYLEA treatment
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to investigate the safety and effectiveness of EYLEA
Read the detailed description
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.
For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
- Conditions
- Macular Edema
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- Keywords
- Aflibercept, anti-VEGF
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
Administration by intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept (Eylea,BAY86-5321) | Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants of Adverse Events
Measured: Up to 12 months
Number of participants of Serious Adverse Events
Measured: Up to 12 months
Secondary outcomes (2)
Mean change in visual acuity from baseline to 12 months
Measured: Baseline to 12 months
Mean change in retina thickness from baseline to 12 months
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start20 Jan 2015
- Primary completion26 Apr 2019
- Study completion13 Aug 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 Macular EdemaStudies 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
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425501
- Sponsor's protocol ID
- 17544
- Other IDs
- EY1510JP
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2015
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sugimoto M, Handa C, Hirano K, Sunaya T, Kondo M. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3489-3498. doi: 10.1007/s00417-022-05703-9. Epub 2022 Jun 2.
PubMed 35652946
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02425501
- Acronym / sponsor ID
- 17544
- Conditions
- Macular Edema
- Keywords
- Aflibercept, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 24 Apr 2015 (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 objectives of this study are to investigate the safety and effectiveness of EYLEA
Detailed description
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.
For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept (Eylea,BAY86-5321) | – | Drug: Aflibercept (Eylea, BAY86-5321)Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female and male patients with DME diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.
Key inclusion criteria (1 listed)
- Patients who start EYLEA treatment for Diabetic Macular Edema (DME)
Key exclusion criteria (1 listed)
- Patients who have already received EYLEA treatment
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, BAY86-5321)Administration by intravitreal injection | Drug | Aflibercept (Eylea,BAY86-5321) |
Primary outcome
Number of participants of Adverse Events
Time frame: Up to 12 months
Number of participants of Serious Adverse Events
Time frame: Up to 12 months
2 secondary outcomes
Mean change in visual acuity from baseline to 12 months
Time frame: Baseline to 12 months
Mean change in retina thickness from baseline to 12 months
Time frame: Baseline to 12 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 11 Jan 2023.
- Derived from this study: PubMed 35652946Sugimoto M, Handa C, Hirano K, Sunaya T, Kondo M. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3489-3498. doi: 10.1007/s00417-022-05703-9. Epub 2022 Jun 2.
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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 Macular Edema, run by Bayer at 1 site in Japan.
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 1 inclusion and 1 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 11 Jan 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 Japan. 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?
Number of participants of Adverse Events (time frame: Up to 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?
On the ClinicalTrials.gov record for NCT02425501, 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 11 Jan 2023.