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NCT Number: NCT05705258

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

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

Primary outcomes

  1. Incidence of any treatment-emergent adverse events (TEAEs)

    Time frame: Up to 6 months after initiation of Aflibercept

Secondary outcomes

  1. Proportion of patients who improvement of the activity of ROP

    Time frame: At month 1 or month 6 after initiation of Aflibercept

    Active ROP will be assessed by investigator

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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