Clinical trial NCT04939571: European Disease Registry on Retinopathy of Prematurity (ROP)
Official title: European Disease Registry on Retinopathy of Prematurity (ROP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinopathy of Prematurity
Keywords: ROP
anti-VEGF
laser coagulation
epidemiology
non-interventional study
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* ROP requiring treatment according to the respective national ROP screening and treatment guidelines

Exclusion Criteria:

* Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians

Primary outcomes:
measure: Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
timeFrame: Birth to treatment of ROP, an average of 12 weeks
measure: Treatment parameters at initial treatment
timeFrame: An average of 12 weeks postnatal age
measure: Treatment parameters at re-treatment
timeFrame: Through study completion, an average of 20 to 30 weeks postnatal age
measure: ROP stage
timeFrame: Through follow-up after treatment, an average of 1 year postnatal age
Secondary outcomes:
measure: Long-term ophthalmic development
timeFrame: Up to 18 years
measure: Long-term neurologic development
timeFrame: Up to 18 years
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Eye Hospital Salzburg
city: Plovdiv
country: Bulgaria
facility: University Hospital Saint George
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Sofia
country: Bulgaria
facility: University Eye Hospital Alexandrovska
city: Tartu
country: Estonia
facility: University Eye Hospital Tartu
city: Paris
country: France
facility: Hospital Rothschild
city: Aachen
country: Germany
facility: University Eye Hospital
city: Berlin
country: Germany
facility: University Eye Hospital Helios
city: Berlin
country: Germany
facility: University Eye Hospital Vivantes
city: Bonn
country: Germany
facility: University Eye Hospital Bonn
city: Braunschweig
country: Germany
facility: Braunschweig Muncipal Hospital
city: Chemnitz
country: Germany
facility: University Eye Hospital
city: Cologne
country: Germany
facility: University Eye Hospital
city: Cottbus
country: Germany
facility: Carl-Thiem University Hospital Cottbus
city: Düsseldorf
country: Germany
facility: University Eye Hospital
city: Freiburg
country: Germany
facility: University Eye Hospital
city: Fulda
country: Germany
facility: University Eye Hospital Fulda
city: Gießen
country: Germany
facility: University Eye Hospital Gießen
city: Greifswald
country: Germany
facility: University Eye Hospital
city: Göttingen
country: Germany
facility: University Eye Hospital
city: Hamburg
country: Germany
facility: University Eye Hospital
city: Hannover
country: Germany
facility: University Eye Hospital Hannover
city: Ludwigshafen
country: Germany
facility: Facharztpraxis für Augenheilkunde
city: Lübeck
country: Germany
facility: University Eye Hospital
city: Munich
country: Germany
facility: Ludwig-Maximilins-University Munich
city: Münster
country: Germany
facility: Augenzentrum am St. Franziskus-Hospital
city: Münster
country: Germany
facility: University Eye Hospital
city: Nuremberg
country: Germany
facility: Nuremberg South Hospital
city: Potsdam
country: Germany
facility: Ernst-von-Bergmann Hospital
city: Regensburg
country: Germany
facility: University Eye Hospital
city: Tübingen
country: Germany
facility: University Eye Hospital
city: Ulm
country: Germany
facility: University Eye Hospital Ulm
city: Athens
country: Greece
facility: P&A Kyriakou Athens Children Hospital
city: Larissa
country: Greece
facility: Department of Ophthalmology University Hospital of Larissa
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
city: Pristina
country: Kosovo
facility: University Clinical Center of Kosovo
city: Białystok
country: Poland
facility: Medical University of Bialystok Children's Clinical Hospital
city: Bydgoszcz
country: Poland
facility: University Hospital in Bydgoszcz
city: Katowice
country: Poland
facility: University Hospital in Zabrze Silesia
city: Olsztyn
country: Poland
facility: Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital
city: Poznań
country: Poland
facility: University of Medical Sciences Poznan
city: Warsaw
country: Poland
facility: Children's Memorial Health Institute Warsaw
city: Málaga
country: Spain
facility: Biomédica de Málaga y Plataforma en Nanomedicina
city: Valencia
country: Spain
facility: University and Polytechnic Hospital La Fe
city: Geneva
country: Switzerland
facility: University Eye Hospital Genève
city: Adana
country: Turkey
facility: University Eye Hospital Cukurova
city: Ankara
country: Turkey
facility: Etlik Zübeyde Hanim Women's Health Education and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Children's Hospital
city: Ankara
country: Turkey
facility: University Eye Hospital Ankara
city: Ankara
country: Turkey
facility: University Eye Hospital Baskent
city: Ankara
country: Turkey
facility: University Eye Hospital Gazi
city: Bursa
country: Turkey
facility: University Eye Hospital Uludag
city: Istanbul
country: Turkey
facility: Umraniye Research and Education Hospital
city: Istanbul
country: Turkey
facility: University Eye Hospital Koc
city: Ordu
country: Turkey
facility: Ordu University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Eye Hospital
city: Kiev
country: Ukraine
facility: Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev
city: Kiev
country: Ukraine
facility: Kyiv Pediatric Hospital Ohmatdyt
city: Odesa
country: Ukraine
facility: Filatov Institute of Eye Diseases and Tissue Therapy Odessa
Study officials:
affiliation: Department of Ophthalmology, University Medicine Greifswald
name: Andreas Stahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Winter 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.