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Premature Babies' vision tracked years after ROP treatment

NCT ID NCT04515524

Knowledge-focused Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 100 premature babies who were treated for retinopathy of prematurity (ROP) in an earlier study. Researchers will check their eyesight and overall development over time to see how they are doing. No new treatment is given in this study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study will help doctors understand the long-term vision and development of premature babies treated for ROP.
What could go wrong
This is an observational follow-up, not a treatment trial. It cannot prove whether the original treatment works or causes harm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients who were treated in the VGFTe-ROP-1920 study are eligible for enrollment into this follow-up study.

Ages

11 months to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient was treated in study VGFTe-ROP-1920 2. Age \<13 months of chronological age 3. 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 Exclusion Criteria: 1\. Patient has a condition preventing participation in the study, or performance of study procedures NOTE: Other Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinopathy of prematurity

Contacts and locations

Locations

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment

    Sofia, 1407, Bulgaria

  • Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Children's Hospital 1 - Ophthalmology Unit

    Ho Chi Minh City, Thanh Pho, 70000, Vietnam

  • Chulalongkorn University

    Bangkok, Bangkok, 10330, Thailand

  • Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Clinica Universitaria Bolivariana

    Medellín, Antioquia, 050034, Colombia

  • Eskisehir Osmangazi University Medical Faculty Hospital

    Eskişehir, 26480, Turkey (Türkiye)

  • Fundacion Oftalmologica de Santander Foscal

    Floridablanca, Santander Department, 681004, Colombia

  • Gazi University Medical Faculty Hospital

    Ankara, 06560, Turkey (Türkiye)

  • Hacettepe University Medical Faculty

    Ankara, 06230, Turkey (Türkiye)

  • Hue Central Hospital

    Huế, Thừa Thiên Huế Province, 530000, Vietnam

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Lifespan - Women & Infants Hospital of RI

    Providence, Rhode Island, 02905, United States

  • Loma Linda University Eye Institute

    Loma Linda, California, 92354, United States

  • New York University School of Medicine - Oncology

    New York, New York, 10016, United States

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Prince of Songkla University - Ophthalmology

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Queen Sirikit National Institute Of Child Health - Pediatrics

    Bangkok, 10400, Thailand

  • SBU Adana Sehir Training and Research Hospital

    Adana, 4522, Turkey (Türkiye)

  • SC Centrul Medical Unirea SRL

    Iași, 700023, Romania

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • Specialized Hospital for Active Treatment of Eye Diseases - Varna

    Varna, 9002, Bulgaria

  • Srinagarind Hospital - Ophthalmology

    Khon Kaen, 4002, Thailand

  • St. Petersburg State Pediatric Medical University - ophtalmology

    Saint Petersburg, 194100, Russia

  • The Children's Hospital of San Antonio

    San Antonio, Texas, 78240, United States

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla, California, 92093-0946, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco - Ophthalmology

    San Francisco, California, 94158, United States

  • V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology

    Moscow, Moscow, 119620, Russia

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.