Neovascular Age-related Macular Degeneration (nAMD)NCT06929143
A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema
An observational study of Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME), run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME)
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteJapan
- Study dates
- 14 Apr 2025to 30 Jul 2027
- Phase
- Observational
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: Samples will be taken from the DeSC healthcare insurance database. This database contains information of 12 million individuals and has in a previous study been found to be demographically distributed in a similar manner to the Japanese population.
Who may be able to join
- Patients who are prescribed aflibercept 8 mg during the observable period from the collected data.
Who cannot join
- Patients in the nAMD cohort or nAMD and DME cohort who have the ICD-10 codes for nAMD who are aged <40 years old.
- Patients in the DME cohort or others who are aged <18 years old.
- Female patients who have any pregnancy-related records.
- Patients who do not have at least 365 days of continuous enrollment in the database.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Utilization Patterns of Aflibercept 8 mg in Japan: a Retrospective Descriptive Study Using the Claims Database
This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision.
Read more
Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which causes abnormal growth and leakage of blood vessels at the back of the eye.
The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors.
There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations.
The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it.
To learn this, the study will use 2 methods:
Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg.
Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg.
The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2.
Researchers will only look at the information from participants in Japan.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
- Being tested
- Aflibercept (Eylea, BAY86-5321)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
8 mg (0.07 mL) intravitreal (IVT) injection (114.3mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| Patients with neovascular Age-related Macular Degeneration (nAMD) | Patients with any International Classification of Diseases, Tenth revision (ICD-10) codes for nAMD or possible nAMD within the same month of the cohort entry date (except for patients who meet the nAMD/DME cohort definition). Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| Patients with Diabetic Macular Edema (DME) | Patients with any ICD-10 codes for DME or possible DME within the same month of the cohort entry date (except for patients who meet the nAMD/DME cohort definition). Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| Patients with nAMD/DME | Patients who have ICD-10 codes for nAMD, possible nAMD, DME, and possible DME within the same month of the cohort entry date. Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| Other patients | Patients with no ICD-10 codes for nAMD, possible nAMD, DME, and possible DME within the same month of the cohort entry date. Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of baseline characteristics of patients with nAMD or DME who initiated aflibercept 8 mg under real-world conditions.
Measured: At baseline.
Description of the longitudinal patterns of treatment interval of patients with nAMD or DME who initiated aflibercept 8 mg.
Measured: Within 12 months.
Secondary outcomes (4)
Change of treatment interval of patients with nAMD or DME who are treated with other anti-VEGF therapy.
Measured: Before and 12 months after initiation of aflibercept 8 mg.
Number of injections of aflibercept 8 mg in patients with nAMD or DME.
Measured: Within 3 months, 6 months, and 12 months after the first prescription date of aflibercept 8 mg.
Predicting factors of the patterns of the treatment interval of aflibercept 8 mg in patients with nAMD or DME.
Measured: Within 12 months.
Proportion of patients who continue the aflibercept 8 mg.
Measured: Within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start14 Apr 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929143
- Sponsor's protocol ID
- 22905
- Status last verified
- May 2026
- First submitted
- 8 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.