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)

NCT05705258 | Recruiting

• 1 other identifier: 22069
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinopathy of Prematurity; Newborns; Infants

Keywords

ROP

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment-emergent adverse events (TEAEs)

  Up to 6 months after initiation of Aflibercept

Secondary Outcomes (1)

• Proportion of patients who improvement of the activity of ROP

  At month 1 or month 6 after initiation of Aflibercept

Study Arms (1)

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)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

Treatment with Intravitreal (IVT)-AFL must be made by the treating ophthalmologist

Aflibercept treatment

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Japan

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: March 27, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)