MedTrace Logo

European Disease Registry on Retinopathy of Prematurity (ROP)

NCT04939571 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-01-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Andreas Stahl, Professor · Department of Ophthalmology, University Medicine Greifswald

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2038-08-31
Completion
2039-08-31

Countries

  • Austria
  • Bulgaria
  • Estonia
  • France
  • Germany
  • Greece
  • Kosovo
  • Poland
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939571 on ClinicalTrials.gov