Project firefleye next – An extension study to evaluate the long-term outcomes of subjects who received treatment for…

Basic data

Acronym:
firefleye next
Title:
An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090
Duration:
10/10/2019 to 31/12/2025
Abstract / short description:
Data assessing the efficacy, safety, tolerability, and systemic exposure
to aflibercept versus laser photocoagulation in subjects with ROP will be generated in Study 20090, a phase 3, multicenter, 2-arm study. All treated patients from Study 20090 must be offered participation in a follow-up study 20275 until they are 5 years of age to assess ocular effects, clinical and neurodevelopmental outcomes. Subjects will be followed until the age of
5 years, when detailed assessment of visual function and overall development becomes feasible and stable. No study treatment is planned. In case any treatment for recurrence of ROP is required, subjects will be allowed to receive treatment according to the local standard of care.
Keywords:
retinopathy of prematurity
aflibercept
longterm outcomes

Involved staff

Managers

Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine

Contact persons

Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine

Other staff

University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine

Local organizational units

University Eye Hospital
Center for Ophthalmology
Hospitals and clinical institutes, Faculty of Medicine
Paediatrics Department IV
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine

Funders

Leverkusen, Nordrhein-Westfalen, Germany
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