European Disease Registry on Retinopathy of Prematurity (ROP)

Retinopathy of Prematurity Clinical Trial

— EU-ROP  

Official title:

European Disease Registry on Retinopathy of Prematurity (ROP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04939571
• Other study ID #: EU-ROP
• Status: Recruiting
• Start date: August 6, 2021
• Est. completion date: August 2039

Study information

• Verified date: January 2024
• Source: University Medicine Greifswald
• Contact: Andreas Stahl, Professor
• Phone: +49 3834 86
• Email: andreas.stahl[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2039
• Est. primary completion date: August 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Registry of preterm born infants with treatment-requiring ROP
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.

Locations

Country	Name	City	State
Austria	University Eye Hospital Salzburg	Salzburg
Bulgaria	University Hospital Saint George	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Bulgaria	University Eye Hospital Alexandrovska	Sofia
Estonia	University Eye Hospital Tartu	Tartu
France	Hospital Rothschild	Paris
Germany	University Eye Hospital	Aachen
Germany	University Eye Hospital Helios	Berlin
Germany	University Eye Hospital Vivantes	Berlin
Germany	University Eye Hospital Bonn	Bonn
Germany	Braunschweig Muncipal Hospital	Braunschweig
Germany	University Eye Hospital	Chemnitz
Germany	University Eye Hospital	Cologne
Germany	Carl-Thiem University Hospital Cottbus	Cottbus
Germany	University Eye Hospital	Düsseldorf
Germany	University Eye Hospital	Freiburg
Germany	University Eye Hospital Fulda	Fulda
Germany	University Eye Hospital Gießen	Gießen
Germany	University Eye Hospital	Göttingen
Germany	University Eye Hospital	Greifswald
Germany	University Eye Hospital	Hamburg
Germany	University Eye Hospital Hannover	Hannover
Germany	University Eye Hospital	Lübeck
Germany	Facharztpraxis für Augenheilkunde	Ludwigshafen
Germany	Ludwig-Maximilins-University Munich	Munich
Germany	Augenzentrum am St. Franziskus-Hospital	Münster
Germany	University Eye Hospital	Münster
Germany	Nuremberg South Hospital	Nuremberg
Germany	Ernst-von-Bergmann Hospital	Potsdam
Germany	University Eye Hospital	Regensburg
Germany	University Eye Hospital	Tübingen
Germany	University Eye Hospital Ulm	Ulm
Greece	P&A Kyriakou Athens Children Hospital	Athens
Greece	Department of Ophthalmology University Hospital of Larissa	Larissa
Greece	Aristotle University of Thessaloniki	Thessaloníki
Kosovo	University Clinical Center of Kosovo	Pristina
Poland	Medical University of Bialystok Children's Clinical Hospital	Bialystok
Poland	University Hospital in Bydgoszcz	Bydgoszcz
Poland	University Hospital in Zabrze Silesia	Katowice
Poland	Prof. Dr. Stanislaw Popowski Regional Specialized Children's Hospital	Olsztyn
Poland	University of Medical Sciences Poznan	Poznan
Poland	Children's Memorial Health Institute Warsaw	Warsaw
Spain	Biomédica de Málaga y Plataforma en Nanomedicina	Málaga
Spain	University and Polytechnic Hospital La Fe	Valencia
Switzerland	University Eye Hospital Genève	Geneva
Turkey	University Eye Hospital Cukurova	Adana
Turkey	Etlik Zübeyde Hanim Women's Health Education and Research Hospital	Ankara
Turkey	Hacettepe University Children's Hospital	Ankara
Turkey	University Eye Hospital Ankara	Ankara
Turkey	University Eye Hospital Baskent	Ankara
Turkey	University Eye Hospital Gazi	Ankara
Turkey	University Eye Hospital Uludag	Bursa
Turkey	Umraniye Research and Education Hospital	Istanbul
Turkey	University Eye Hospital Koc	Istanbul
Turkey	Ordu University Medical Faculty	Ordu
Turkey	Ondokuz Mayis University Eye Hospital	Samsun
Ukraine	Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev	Kiev
Ukraine	Kyiv Pediatric Hospital Ohmatdyt	Kiev
Ukraine	Filatov Institute of Eye Diseases and Tissue Therapy Odessa	Odesa

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Countries where clinical trial is conducted

Austria,  Bulgaria,  Estonia,  France,  Germany,  Greece,  Kosovo,  Poland,  Spain,  Switzerland,  Turkey,  Ukraine, 

References & Publications (2)

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. 2023 Sep 13:bjo-2023-323915. doi: 10.1136/bjo-2023-323915. Online ahead of print. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Birth to treatment of ROP, an average of 12 weeks
Primary	Treatment parameters at initial treatment	Type of treatment	An average of 12 weeks postnatal age
Primary	Treatment parameters at re-treatment	Type of treatment	Through study completion, an average of 20 to 30 weeks postnatal age
Primary	ROP stage	Stage of ROP at treatment and during follow-up	Through follow-up after treatment, an average of 1 year postnatal age
Secondary	Long-term ophthalmic development	Ophthalmic development (e.g. orthoptic status, visual acuity)	Up to 18 years
Secondary	Long-term neurologic development	Neurological developmental (e.g. assessed by psychometric assessments)	Up to 18 years

External Links

•   Project website