Project firefleye – A randomized, 2-arm, open-label, phase 3 study to evaluate the efficacy, safety, and tolerability of…

Basic data

Acronym:
firefleye
Title:
A randomized, 2-arm, open-label, phase 3 study to evaluate the efficacy, safety, and tolerability of intravitreal aflibercept versus laser photocoagulation in subjects with retinopathy of prematurity
Duration:
10/10/2019 to 31/12/2020
Abstract / short description:
Currently available clinical data indicate potential advantages of the
use of IVT anti-VEGF agents, including aflibercept, compared to laser photocoagulation for treatment of ROP, and caused a gradual but steady increase in off-label use of IVT anti-VEGF agents in this condition. However, currently available prospective and longer-term data on the use of aflibercept for the treatment of ROP are still insufficient. The efficacy of IVT aflibercept in a well-characterized population of patients with ROP still needs to be evidenced by data from a prospective clinical trial. Knowledge of the benefit-risk profile for this population needs to be improved, and the pharmacokinetic parameters of aflibercept need to be more fully characterized taking into account the characteristics and limitations of this premature newborn population. These data are planned to be generated in a clinical development program including this randomized, phase 3, multicenter, 2-arm, open-label clinical study to assess the efficacy, safety, and tolerability of IVT aflibercept in subjects with ROP.
Keywords:
retinopathy of prematurity
aflibercept

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

Funders

Leverkusen, Nordrhein-Westfalen, Germany
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