Retinopathy of PrematurityNCT05705258
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)
An observational study of Retinopathy of Prematurity and Newborns, run by Bayer at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Retinopathy of Prematurity, Newborns, Infants
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- 27 Mar 2023to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- Keywords
- ROP
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
Treatment with Intravitreal (IVT)-AFL must be made by the treating ophthalmologist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any treatment-emergent adverse events (TEAEs)
Measured: Up to 6 months after initiation of Aflibercept
Secondary outcomes (1)
Proportion of patients who improvement of the activity of ROP
Active ROP will be assessed by investigator
Measured: At month 1 or month 6 after initiation of Aflibercept
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start27 Mar 2023
- Primary completion6 Feb 2026
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705258
- Sponsor's protocol ID
- 22069
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for Eylea for Retinopathy of Prematurity (ROP)
- ClinicalTrials.gov ID
- NCT05705258
- Acronym / sponsor ID
- 22069
- Conditions
- Retinopathy of Prematurity, Newborns, Infants
- Keywords
- ROP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept treatment | – | Drug: Aflibercept (Eylea, BAY86-5321)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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321)Treatment with Intravitreal (IVT)-AFL must be made by the treating ophthalmologist | Drug | Aflibercept treatment |
Primary outcome
Incidence of any treatment-emergent adverse events (TEAEs)
Time frame: Up to 6 months after initiation of Aflibercept
1 secondary outcome
Proportion of patients who improvement of the activity of ROP
Time frame: At month 1 or month 6 after initiation of Aflibercept
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity and Newborns, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any treatment-emergent adverse events (TEAEs) (time frame: Up to 6 months after initiation of Aflibercept). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.