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

Not yet recruiting

• Conditions: Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME)
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT06929143
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study Start: 2025-04-14
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with neovascular Age-related Macular Degeneration (nAMD)	Aflibercept (Eylea, BAY86-5321)	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).
Patients with Diabetic Macular Edema (DME)	Aflibercept (Eylea, BAY86-5321)	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).
Patients with nAMD/DME	Aflibercept (Eylea, BAY86-5321)	Patients who have ICD-10 codes for nAMD, possible nAMD, DME, and possible DME within the same month of the cohort entry date.
Other patients	Aflibercept (Eylea, BAY86-5321)	Patients with no ICD-10 codes for nAMD, possible nAMD, DME, and possible DME within the same month of the cohort entry date.

Primary Outcome Measures

Name	Time	Method
Description of baseline characteristics of patients with nAMD or DME who initiated aflibercept 8 mg under real-world conditions.	At baseline.
Description of the longitudinal patterns of treatment interval of patients with nAMD or DME who initiated aflibercept 8 mg.	Within 12 months.

Secondary Outcome Measures

Name	Time	Method
Change of treatment interval of patients with nAMD or DME who are treated with other anti-VEGF therapy.	Before and 12 months after initiation of aflibercept 8 mg.
Number of injections of aflibercept 8 mg in patients with nAMD or DME.	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.	Within 12 months.
Proportion of patients who continue the aflibercept 8 mg.	Within 12 months.

Trial Locations

Locations (1)

Bayer; 🇯🇵 Osaka, Japan