Retinopathy of PrematurityNCT04515524
Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)
An observational study of Retinopathy of Prematurity, run by Regeneron Pharmaceuticals at 30 sites in 10 countries.
Trial summary
Primary objectives of the study are: To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP). To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. Read more about this study
- Who is it for?
- Ages 11 months to 5 years
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Non-Interventional
- How many people
- 100 participants
- Where
- 30 sitesin 10 countries
- Study dates
- 5 Feb 2021to 5 Nov 2026
- 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 11 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients who were treated in the VGFTe-ROP-1920 study are eligible for enrollment into this follow-up study.
Who may be able to join
- Patient was treated in study VGFTe-ROP-1920
- Age <13 months of chronological age
- Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- 1. Patient has a condition preventing participation in the study, or performance of study procedures
- NOTE: Other Inclusion/Exclusion criteria may apply
Trial locations and contacts
30 sites in 10 countries.
30 sites in 10 countries
United States9 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093-0946
Loma Linda University Eye Institute
Loma Linda, California, 92354
West Virginia University
Morgantown, West Virginia, 26506
New York University School of Medicine - Oncology
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lifespan - Women & Infants Hospital of RI
Providence, Rhode Island, 02905
The Children's Hospital of San Antonio
San Antonio, Texas, 78240
University of California San Francisco - Ophthalmology
San Francisco, California, 94158
Thailand6 sites
Chulalongkorn University
Bangkok, Bangkok, 10330
Phramongkutklao Hospital
Bangkok, 10400
Queen Sirikit National Institute Of Child Health - Pediatrics
Bangkok, 10400
Chiang Mai University
Chiang Mai, 50200
Prince of Songkla University - Ophthalmology
Hat Yai, Changwat Songkhla, 90110
Srinagarind Hospital - Ophthalmology
Khon Kaen, 4002
Turkey (Türkiye)4 sites
SBU Adana Sehir Training and Research Hospital
Adana, 4522
Hacettepe University Medical Faculty
Ankara, 06230
Gazi University Medical Faculty Hospital
Ankara, 06560
Eskisehir Osmangazi University Medical Faculty Hospital
Eskişehir, 26480
Bulgaria2 sites
Acibadem City Clinic Multiprofile Hospital for Active Treatment
Sofia, 1407
Specialized Hospital for Active Treatment of Eye Diseases - Varna
Varna, 9002
Colombia2 sites
Fundacion Oftalmologica de Santander Foscal
Floridablanca, Santander Department, 681004
Clinica Universitaria Bolivariana
Medellín, Antioquia, 050034
Russia2 sites
V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology
Moscow, Moscow, 119620
St. Petersburg State Pediatric Medical University - ophtalmology
Saint Petersburg, 194100
Vietnam2 sites
Children's Hospital 1 - Ophthalmology Unit
Ho Chi Minh City, Thanh Pho, 70000
Hue Central Hospital
Huế, Thừa Thiên Huế Province, 530000
South Korea1 site
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 31151
About this study
Official title: An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
Primary objectives of the study are:
- To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
- To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Secondary objectives of the study are:
- To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
- To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Non-Interventional
- 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.
Non-InterventionalOther
No study treatment will be administered in this study
| Study group | Role | What they receive |
|---|---|---|
| ROP patients from VGFTe-ROP-1920 | Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular best-corrected visual acuity (BCVA)
Measured: 5 years of chronological age
Proportion of Patients with Adverse Events
Measured: Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events
Measured: Up to 5 years of chronological age
Secondary outcomes (8)
Proportion of patients developing unfavorable ocular structural outcome
Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity
Measured: 3 years of chronological age, 5 years of chronological age
BCVA in each eye
Measured: 3 year of chronological age, 5 years of chronological age
Refractive spherical equivalent in each eye
Measured: 3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using BSID-III
The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. This is a mandatory assessment to be performed at 2 years of age.
Measured: 2 years of chronological age
Neurodevelopmental outcomes using WPPSI-IV
The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.
Measured: 5 years of chronological age
Neurodevelopmental outcomes using VABS-II
The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. The assessments at 2 years and 5 years of age are mandatory.
Measured: 2 years of chronological age, 5 years of chronological age
Proportion of patients with recurrence of ROP
Measured: 3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROP
Measured: Through 5 years of chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start5 Feb 2021
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Nov 2026 (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 Regeneron PharmaceuticalsThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515524
- Sponsor's protocol ID
- VGFTe-ROP-2036
- Other IDs
- 2020-005875-10, 2024-513231-24-00
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
- ClinicalTrials.gov ID
- NCT04515524
- Acronym / sponsor ID
- VGFTe-ROP-2036
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 17 Aug 2020 (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.
Primary objectives of the study are:
- To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
- To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Secondary objectives of the study are:
- To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
- To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROP patients from VGFTe-ROP-1920 | – | Other: Non-InterventionalRetinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920. |
Who may qualify
- Ages
- 11 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients who were treated in the VGFTe-ROP-1920 study are eligible for enrollment into this follow-up study.
Key inclusion criteria (3 listed)
- Patient was treated in study VGFTe-ROP-1920
- Age <13 months of chronological age
- Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Key exclusion criteria (2 listed)
- 1. Patient has a condition preventing participation in the study, or performance of study procedures
- NOTE: Other Inclusion/Exclusion criteria may apply
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 |
|---|---|---|
| Non-InterventionalNo study treatment will be administered in this study | Other | ROP patients from VGFTe-ROP-1920 |
Primary outcome
Binocular best-corrected visual acuity (BCVA)
Time frame: 5 years of chronological age
Proportion of Patients with Adverse Events
Time frame: Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events
Time frame: Up to 5 years of chronological age
8 secondary outcomes
Proportion of patients developing unfavorable ocular structural outcome
Time frame: 3 years of chronological age, 5 years of chronological age
BCVA in each eye
Time frame: 3 year of chronological age, 5 years of chronological age
Refractive spherical equivalent in each eye
Time frame: 3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using BSID-III
Time frame: 2 years of chronological age
Neurodevelopmental outcomes using WPPSI-IV
Time frame: 5 years of chronological age
Neurodevelopmental outcomes using VABS-II
Time frame: 2 years of chronological age, 5 years of chronological age
Proportion of patients with recurrence of ROP
Time frame: 3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROP
Time frame: Through 5 years of chronological age
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
30 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Regeneron Pharmaceuticals at 30 sites in 10 countries.
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 2 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Thailand, Turkey (Türkiye), Bulgaria, Colombia and 5 more countries. 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?
Binocular best-corrected visual acuity (BCVA) (time frame: 5 years of chronological age). The study lists 3 primary outcomes in all. 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 27 Mar 2026.