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)

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705258
• Other study ID #: 22069
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: March 30, 2027

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 30, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Infants
• Newborns
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
Treatment with Intravitreal (IVT)-AFL must be made by the treating ophthalmologist

Locations

Country	Name	City	State
Japan	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any treatment-emergent adverse events (TEAEs)		Up to 6 months after initiation of Aflibercept
Secondary	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

External Links

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