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Baby eye treatment checked years later: did it last?

NCT ID NCT04015180

Knowledge-focused Sponsor: Bayer 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed about 100 babies who were treated for retinopathy of prematurity (ROP) with either Eylea injections or laser therapy in an earlier trial. Researchers checked their vision and eye health years later to see how well the treatments held up. The goal is to understand long-term safety and effectiveness.

What this could mean

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

Active substance
Aflibercept (Eylea) injection or laser photocoagulation
What this could lead to
If successful, this study will show how well these treatments work over the long term for vision and eye health in premature babies.
What could go wrong
This is a follow-up study, not a new treatment test. Results may not apply to all babies, and some children may still have vision problems.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

100 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2025

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.

Ages

Up to 13 months

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: * Subject was treated in Study 20090 * Age less than 13 months of chronological age * Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: \- Subject has a condition preventing participation in the study, or performance of study procedures.

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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 (ROP)

Contacts and locations

Locations

  • A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica

    Perugia, Umbria, 06129, Italy

  • AZ Sint Jan Brugge - Ophthalmology

    Bruges, 8000, Belgium

  • Acibadem City Clinic Multiprofile Hospital for Active Treatm

    Sofia, 1407, Bulgaria

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Yüreğir, 1370, Turkey (Türkiye)

  • Asan Medical Center - Oncology Department

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Birmingham Womens Hospital

    Birmingham, B15 2TG, United Kingdom

  • Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department

    Athens, MISSING, Greece

  • City Children Hospital ?1

    Saint Petersburg, 198205, Russia

  • Clinical Emergency County Hospital

    Cluj-Napoca, Cluj, 400347, Romania

  • Eskisehir Osmangazi Universitesi Tip Fakultesi

    Eskişehir, 26480, Turkey (Türkiye)

  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo

    Budapest, H-1125, Hungary

  • FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"

    Moscow, 119620, Russia

  • FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch

    Kaluga, 248007, Russia

  • Fakultní nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica

    Milan, Lombardy, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica

    Rome, Lazio, 00136, Italy

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • Fukushima Medical University Hospital

    Fukushima, 960-1295, Japan

  • Gazi Universitesi Tip Fakultesi

    Ankara, 6560, Turkey (Türkiye)

  • General Hospital Of Thessaloniki Papageorgiou-2nd Ophthalmology Clinic

    Efkarpia, 564 29, Greece

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 6100, Turkey (Türkiye)

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Prof. Dr. Fernando Fonseca

    Amadora, Lisbon District, 2720-276, Portugal

  • Hospital Público Descentralizado "Dr. Guillermo Rawson"

    San Juan, 5400, Argentina

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Regional De Malaga - Oftalmologia

    Málaga, 29011, Spain

  • Hospital das Clínicas de Botucatu - UNESP Botucatu

    Botucatu, São Paulo, TBC, Brazil

  • Hospital la Paz - oftalmologia

    Madrid, 28046, Spain

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu, Fukuoka, 807-8556, Japan

  • Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic

    Odesa, 65061, Ukraine

  • KK Women's and Children's Hospital

    Singapore, 229899, Singapore

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Kaohsiung, 807377, Taiwan

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Mackay Memorial Hospital

    Taipei, 104, Taiwan

  • Maxima Medisch Centrum, locatie Veldhoven

    Veldhoven, 5504 DB, Netherlands

  • Narodny ustav detskych chorob

    Bratislava, 833 41, Slovakia

  • Okinawa Prefectural Nanbu Medical Center and Children's MC

    Shimajiri-gun, Okinawa, 901-1193, Japan

  • Ospedale Pediatrico Bambino Gesù - Oculistica

    Rome, Lazio, 00165, Italy

  • Saglik Bilimleri Universitesi Antalya EA Hastanesi

    Antalya, 7100, Turkey (Türkiye)

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45, Sweden

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna

    Varna, 9000, Bulgaria

  • Spec. Hospital of Ophthalm. for Active Treatment Visus

    Sofia, 1619, Bulgaria

  • Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"

    Iași, 700038, Romania

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida-ku, Tokyo, 130-8575, Japan

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center

    Fuchū, Tokyo, 183-8561, Japan

  • Tokyo Metropolitan Ohtsuka Hospital

    Toshima-ku, Tokyo, 170-8476, Japan

  • UMHAT Sveti Georgi

    Plovdiv, 4002, Bulgaria

  • Unidade Local De Saúde De Lisboa Ocidental E.P.E.

    Lisbon, 1449-005, Portugal

  • Unifesp/Epm

    São Paulo, 04024-002, Brazil

  • University General Hospital of Ioannina

    Ioannina, 45500, Greece

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12808, Czechia

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