NCT04939571

European Disease Registry on Retinopathy of Prematurity (ROP)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-06
• Primary completion: 2038-08-01
• Completion: 2039-08-01
• First posted: 2021-06-25
• Last updated: 2024-01-24

Locations

59 sites across 12 countries: Austria, Bulgaria, Estonia, France, Germany, Greece, Kosovo, Poland, Spain, Switzerland, Turkey (Türkiye), Ukraine