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European Disease Registry on Retinopathy of Prematurity (ROP) - Trial NCT04939571

Access comprehensive clinical trial information for NCT04939571 through Pure Global AI's free database. This phase not specified trial is sponsored by University Medicine Greifswald and is currently Recruiting. The study focuses on Retinopathy of Prematurity. Target enrollment is 3000 participants.

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NCT04939571
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Trial Details
ClinicalTrials.govNCT04939571
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European Disease Registry on Retinopathy of Prematurity (ROP)

Study Focus

Registry of preterm born infants with treatment-requiring ROP

Observational

other

Sponsor & Location

University Medicine Greifswald

Aachen,Berlin,Berlin,Chemnitz,Cologne,Düsseldorf,Freiburg,Greifswald,Göttingen,Hamburg,Lübeck,Münster,Regensburg,Tübingen, Germany

Timeline & Enrollment

N/A

Aug 06, 2021

Aug 01, 2039

3000 participants

Primary Outcome

Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity,Treatment parameters at initial treatment,Treatment parameters at re-treatment,ROP stage

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.

ICD-10 Classifications

Retinopathy of prematurity
Other proliferative retinopathy
Background retinopathy and retinal vascular changes
Diabetic retinopathy
Retinal disorder, unspecified

Data Source

ClinicalTrials.gov

NCT04939571

Non-Device Trial