European Disease Registry on Retinopathy of Prematurity (ROP)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• 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)
• 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
• ROP stage — Through follow-up after treatment, an average of 1 year postnatal age
  Stage of ROP at treatment and during follow-up

Trial sites (59)

+ 19 more sites — see the full list on the official registry below.