CompletedPhase 3

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

Argentina, Belgium, Brazil100 participantsStarted 2020-03-18

Plain-language summary

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Who can participate

Age range13 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject was treated in Study 20090 * Age less than 13 months of chronological age * Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: \- Subject has a condition preventing participation in the study, or performance of study procedures.

What they're measuring

Binocular best-corrected visual acuity in Snellen equivalent

Timeframe: At 5 years of age.

Proportion of subjects with ocular AEs and SAEs

Timeframe: Up to 5 years of age.

Proportion of subjects with systemic AEs and SAEs

Timeframe: Up to 5 years of age.

Trial details

NCT IDNCT04015180

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-19

View on ClinicalTrials.gov More Retinopathy of Prematurity (ROP) trials