Retinopathy of PrematurityEU-ROPNCT04939571
European Disease Registry on Retinopathy of Prematurity (ROP)
An observational study of Retinopathy of Prematurity, run by University Medicine Greifswald at 59 sites in 12 countries.
Trial summary
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Registry of preterm born infants with treatment-requiring ROP
- How many people
- 3,000 participants
- Where
- 59 sitesin 12 countries
- Study dates
- 6 Aug 2021to Aug 2039
- How long will I take part?
- 18 Years
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infants Europe wide with ROP requiring treatment can be entered into the registry. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.
Who may be able to join
- ROP requiring treatment according to the respective national ROP screening and treatment guidelines
Who cannot join
- Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
Trial locations and contacts
59 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 12 countries
Germany26 sites, 26 recruiting
- Recruiting
University Eye Hospital
Aachen
Peter Walter
- Recruiting
University Eye Hospital Helios
Berlin
Helge Breuss
- Recruiting
University Eye Hospital Vivantes
Berlin
Sabine Aisenbrey
- Recruiting
University Eye Hospital Bonn
Bonn
Raffael Liegl
- Recruiting
Braunschweig Muncipal Hospital
Braunschweig
Erik Chankiewitz
- Recruiting
University Eye Hospital
Chemnitz
Vinodh Kakkassery
- Recruiting
University Eye Hospital
Cologne
Tim U Krohne
- Recruiting
Carl-Thiem University Hospital Cottbus
Cottbus
Lars Geerdts
- Recruiting
University Eye Hospital
Düsseldorf
Rainer Guthoff
- Recruiting
University Eye Hospital
Freiburg im Breisgau
Wolf A Lagrèze
- Recruiting
University Eye Hospital Fulda
Fulda
Iva-Ruth Barthmann
- Recruiting
University Eye Hospital Gießen
Giessen
Monika Andrassi-Darida
- Recruiting
University Eye Hospital
Göttingen
Mohammed Khattab
- Recruiting
University Eye Hospital
Greifswald
Andreas Stahl
- Recruiting
University Eye Hospital
Hamburg
Martin Spitzer
- Recruiting
University Eye Hospital Hannover
Hanover
Karsten Hufendiek
- Recruiting
University Eye Hospital
Lübeck
Salvatore Grisanti
- Recruiting
Facharztpraxis für Augenheilkunde
Ludwigshafen
Waldemar Jendritza
- Not yet recruiting
Ludwig-Maximilins-University Munich
Munich
Oliver Ehrt
- Recruiting
Augenzentrum am St. Franziskus-Hospital
Münster
Georg Spital
- Recruiting
University Eye Hospital
Münster
Barbara Glitz
- Recruiting
Nuremberg South Hospital
Nuremberg
Florian Bauer
- Recruiting
Ernst-von-Bergmann Hospital
Potsdam
Ameli Gabel-Pfisterer
- Recruiting
University Eye Hospital
Regensburg
Teresa Barth
- Recruiting
University Eye Hospital
Tübingen
Daniela Süsskind
- Recruiting
University Eye Hospital Ulm
Ulm
Armin Wolf
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
University Eye Hospital Cukurova
Adana
Hacer Y Yildizdas
- Recruiting
Etlik Zübeyde Hanim Women's Health Education and Research Hospital
Ankara
Caner Kara
- Recruiting
Hacettepe University Children's Hospital
Ankara
Irem Iyigün
- Recruiting
University Eye Hospital Ankara
Ankara
Huban Atilla
- Recruiting
University Eye Hospital Baskent
Ankara
Imren Akkoyun
- Recruiting
University Eye Hospital Gazi
Ankara
Sengul Ozdek
- Recruiting
University Eye Hospital Uludag
Bursa
Nilgun Koksal
- Recruiting
Umraniye Research and Education Hospital
Istanbul
Gulay Karakus
- Recruiting
University Eye Hospital Koc
Istanbul
Ayse Y Tas
- Recruiting
Ordu University Medical Faculty
Ordu
Aslihan Uzun
- Recruiting
Ondokuz Mayis University Eye Hospital
Samsun
Ozlem E Yucel
Poland6 sites, 6 recruiting
- Recruiting
Medical University of Bialystok Children's Clinical Hospital
Bialystok
Monika Ozieblo-Kupczyk
- Recruiting
University Hospital in Bydgoszcz
Bydgoszcz
Magdalena Kaszuba-Modrzejewska
- Recruiting
University Hospital in Zabrze Silesia
Katowice
Bogumila Wójcik-Niklewska
- Recruiting
Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital
Olsztyn
Maria Szwajkowska
- Recruiting
University of Medical Sciences Poznan
Poznan
Anna Gotz-Wieckowska
- Recruiting
Children's Memorial Health Institute Warsaw
Warsaw
Wojciech Hautz
Bulgaria3 sites, 3 recruiting
- Recruiting
University Hospital Saint George
Plovdiv
Vasil G Marinov
- Recruiting
Acibadem City Clinic Tokuda Hospital
Sofia
Lilyana P Dimitrova
- Recruiting
University Eye Hospital Alexandrovska
Sofia
Alexander H Oscar
Greece3 sites, 3 recruiting
- Recruiting
P&A Kyriakou Athens Children Hospital
Athens
Agathi Kouri
- Recruiting
Department of Ophthalmology University Hospital of Larissa
Larissa
Elena Papageorgiou
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki
Asimina Mataftsi
Ukraine3 sites, 3 recruiting
- Recruiting
Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev
Kiev
Lupyr Sergii
- Recruiting
Kyiv Pediatric Hospital Ohmatdyt
Kiev
Kateryna Fedchuk
- Recruiting
Filatov Institute of Eye Diseases and Tissue Therapy Odessa
Odesa
Katsan S Volodymyrovych
Spain2 sites, 2 recruiting
- Recruiting
Biomédica de Málaga y Plataforma en Nanomedicina
Málaga
Julia Escudero
- Recruiting
University and Polytechnic Hospital La Fe
Valencia
Isabel Pascual-Camps
Austria1 site, 1 recruiting
- Recruiting
University Eye Hospital Salzburg
Salzburg
Herbert Reitsamer
Estonia1 site, 1 recruiting
- Recruiting
University Eye Hospital Tartu
Tartu
Mikk Pauklin
Kosovo1 site, 1 recruiting
- Recruiting
University Clinical Center of Kosovo
Pristina
Belinda Pustina
Switzerland1 site, 1 recruiting
- Recruiting
University Eye Hospital Genève
Geneva
Gabriele Thumann
About this study
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed.
The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.
The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Registry of preterm born infants with treatment-requiring ROP
- Keywords
- ROP, anti-VEGF, laser coagulation, epidemiology, non-interventional study
- 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.
Registry of preterm born infants with treatment-requiring ROPOther
All prematurely born infants who develop treatment requiring ROP and are treated (independent of the kind of treatment modality) at a center that participates in the registry are eligible for database entry.
| Study group | Role | What they receive |
|---|---|---|
| Preterm born infants treated for ROP | Not described Receives: Other: Registry of preterm born infants with treatment-requiring ROP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
Birth weight, gestational age, weight at treatment, comorbidities (e.g. sepsis, necrotizing enterocolitis)
Measured: Birth to treatment of ROP, an average of 12 weeks
Treatment parameters at initial treatment
Type of treatment
Measured: An average of 12 weeks postnatal age
Treatment parameters at re-treatment
Type of treatment
Measured: Through study completion, an average of 20 to 30 weeks postnatal age
ROP stage
Stage of ROP at treatment and during follow-up
Measured: Through follow-up after treatment, an average of 1 year postnatal age
Secondary outcomes (2)
Long-term ophthalmic development
Ophthalmic development (e.g. orthoptic status, visual acuity)
Measured: Up to 18 years
Long-term neurologic development
Neurological developmental (e.g. assessed by psychometric assessments)
Measured: Up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start6 Aug 2021
- Primary completionAug 2038 (estimated)
- Study completionAug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Stahl, Professor, Principal investigator, Department of Ophthalmology, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939571
- Sponsor's protocol ID
- EU-ROP
- Acronym
- EU-ROP
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catt C, Pfeil JM, Barthelmes D, Gole GA, Krohne TU, Wu WC, Kusaka S, Zhao P, Dai S, Elder J, Heckmann M, Stack J, Khonyongwa-Fernandez G, Stahl A. Development of a joint set of database parameters for the EU-ROP and Fight Childhood Blindness! ROP Registries. Br J Ophthalmol. 2024 Jun 20;108(7):1030-1037. doi: 10.1136/bjo-2023-323915.
PubMed 37704267Winter K, Pfeil JM, Engmann H, Aisenbrey S, Lorenz B, Hufendiek K, Breuss H, Khattab M, Susskind D, Kakkassery V, Lagreze WA, Barth T, Liegl R, Brunder MC, Skevas C, Goldammer I, Glitz B, Michalewicz E, Krohne TU, Bartmann IR, Stahl A; Retina.net ROP and EU-ROP registry study groups. Comparability of input parameters in the German Retina.net ROP registry and the EU-ROP registry - An exemplary comparison between 2011 and 2021. Acta Ophthalmol. 2024 May;102(3):e314-e321. doi: 10.1111/aos.15753. Epub 2023 Sep 19.
PubMed 37725047