European Disease Registry on Retinopathy of Prematurity (ROP)

Recruiting

• Conditions: Retinopathy of Prematurity

• Registration Number: NCT04939571
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-25
• Study Start: 2021-08-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2038-08
• Study Completion: 2039-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity	Birth to treatment of ROP, an average of 12 weeks	Birth weight, gestational age, weight at treatment, comorbidities (e.g. sepsis, necrotizing enterocolitis)
ROP stage	Through follow-up after treatment, an average of 1 year postnatal age	Stage of ROP at treatment and during follow-up
Treatment parameters at initial treatment	An average of 12 weeks postnatal age	Type of treatment
Treatment parameters at re-treatment	Through study completion, an average of 20 to 30 weeks postnatal age	Type of treatment

Secondary Outcome Measures

Name	Time	Method
Long-term neurologic development	Up to 18 years	Neurological developmental (e.g. assessed by psychometric assessments)
Long-term ophthalmic development	Up to 18 years	Ophthalmic development (e.g. orthoptic status, visual acuity)

Trial Locations

Locations (48)

University Eye Hospital Salzburg; 🇦🇹 Salzburg, Austria

University Hospital Saint George; 🇧🇬 Plovdiv, Bulgaria

Acibadem City Clinic Tokuda Hospital; 🇧🇬 Sofia, Bulgaria

University Eye Hospital Alexandrovska; 🇧🇬 Sofia, Bulgaria

University Eye Hospital Tartu; 🇪🇪 Tartu, Estonia

Hospital Rothschild; 🇫🇷 Paris, France

University Eye Hospital; 🇩🇪 Tübingen, Germany

University Eye Hospital Helios; 🇩🇪 Berlin, Germany

University Eye Hospital Vivantes; 🇩🇪 Berlin, Germany

University Eye Hospital Bonn; 🇩🇪 Bonn, Germany

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