A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)

Special Drug Use Investigation for Eylea for Retinopathy of Prematurity (ROP)

This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without specified advice or interventions.

ROP is a condition that affects the eye and occurs only in babies who are born too early. Most cases of ROP are mild and get better without treatment, but more serious cases need to be treated in time. ROP happens when the blood vessels in the "retina" grow abnormally. The retina is the layer of tissue at the back of the eye that picks up light and sends messages to the brain. In babies with ROP, these abnormal blood vessels can leak. This causes damage to the retina and can sometimes move it out of place causing medical problems such as blindness.

Eylea is received as an injection into the eye. It works by blocking a certain protein (VEGF) that can cause blood vessels in the retina to grow abnormally. Eylea is already available in Japan and is approved for doctors to prescribe to babies with ROP.

The participants in this study are Japanese babies with ROP that their doctors decided to treat with Eylea before the start of this study. Babies with ROP that were already prescribed Eylea by their doctors may also be included.

The main purpose of this study is to collect more data on how safe the treatment with Eylea is in babies with ROP under a real-world setting. Another purpose of this study is to collect more data on how well Eylea works in these participants.

To see how safe Eylea is, the study doctors will collect all medical problems that the participants treated with Eylea have. These medical problems are called adverse events. Doctors keep track of all the adverse events that happen, even if they do not think that they might be related to the treatment.

To see how well Eylea works, the study doctors will check the number of participants:

• with no active ROP after starting treatment
• where ROP came back up to 6 months after start of treatment

In this study, the study doctor will:

• collect past data of the participants from medical records
• interview the participants
• collect treatment-related data during routine visits. The study duration is 6 months with 3 planned visits. One visit will be at start of treatment, one at one month and one at 6 months after start of treatment. All data required for this study will be collected during routine visits. Besides this data collection, no further tests or examinations are planned in this study.

Study Overview

• Status: Active, not recruiting
• Conditions: Retinopathy of Prematurity; Newborns; Infants
• Intervention / Treatment: Drug: Aflibercept (Eylea, BAY86-5321)

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of ROP will be enrolled after the decision for treatment with AFL has been made by the investigator.

Patients who have been prescribed AFL in accordance with the product label in Japan will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.

Description

Inclusion Criteria:

• Diagnosis of ROP requiring treatment
• Patients who have received IVT-AFL treatment according to Japanese approved labeling for AFL in ROP.
• ICF obtained from legal representative.

Exclusion Criteria:

• Patients who have contradictions based on approved label
• Patients who have received IVT-AFL treatment before the treatment for the enrollment Patient.
• Diagnosis of other indication

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aflibercept treatment; The patients will be included in this study by investigators who are prescribing Aflibercept (AFL) routinely in their clinical practice. The enrollment of each patient in this study is able to accept at latest in 6 months from initiation of treatment.	Drug: Aflibercept (Eylea, BAY86-5321); Treatment with Intravitreal (IVT)-AFL must be made by the treating ophthalmologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of any treatment-emergent adverse events (TEAEs)	Up to 6 months after initiation of Aflibercept

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who improvement of the activity of ROP	Active ROP will be assessed by investigator	At month 1 or month 6 after initiation of Aflibercept

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): February 6, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ROP
• Additional Relevant MeSH Terms: Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Retinal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinopathy of Prematurity; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; aflibercept
• Other Study ID Numbers: 22069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No