Status:
COMPLETED
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Retinopathy of Prematurity (ROP)
Eligibility:
All Genders
Up to 13 years
Phase:
PHASE3
Brief Summary
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Eligibility Criteria
Inclusion
- 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
- \- Subject has a condition preventing participation in the study, or performance of study procedures.
Key Trial Info
Start Date :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04015180
Start Date
March 18 2020
End Date
September 19 2025
Last Update
October 10 2025
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Público Descentralizado "Dr. Guillermo Rawson"
San Juan, Argentina, 5400
2
AZ Sint Jan Brugge - Ophthalmology
Bruges, Belgium, 8000
3
Hospital das Clínicas de Botucatu - UNESP Botucatu
Botucatu, São Paulo, Brazil, TBC
4
Unifesp/Epm
São Paulo, Brazil, 04024-002