Clinical trial 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
Official title: Real-world Utilization Patterns of Aflibercept 8 mg in Japan: a Retrospective Descriptive Study Using the Claims Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Diabetic Macular Edema (DME)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

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.


Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed aflibercept 8 mg during the observable period from the collected data.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Description of baseline characteristics of patients with nAMD or DME who initiated aflibercept 8 mg under real-world conditions.
timeFrame: At baseline.
measure: Description of the longitudinal patterns of treatment interval of patients with nAMD or DME who initiated aflibercept 8 mg.
timeFrame: Within 12 months.
Secondary outcomes:
measure: Change of treatment interval of patients with nAMD or DME who are treated with other anti-VEGF therapy.
timeFrame: Before and 12 months after initiation of aflibercept 8 mg.
measure: Number of injections of aflibercept 8 mg in patients with nAMD or DME.
timeFrame: Within 3 months, 6 months, and 12 months after the first prescription date of aflibercept 8 mg.
measure: Predicting factors of the patterns of the treatment interval of aflibercept 8 mg in patients with nAMD or DME.
timeFrame: Within 12 months.
measure: Proportion of patients who continue the aflibercept 8 mg.
timeFrame: Within 12 months.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Bayer
Study officials:
References: