Randomized, Controlled, Multi-Center Study To Assess The Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoaculation in Patients with Retinopathy of Prematurity
This study enrolls newborn infants with treatable retinopathy of prematurity (ROP). ROP is is one of the leading causes of childhood blindness worldwide. The purpose of this study is to learn if aflibercept (Eyelea) works to treat this condition.
Infants in this study will be randomized (like the flip of a coin) to either take the study medication or to have the usual standard of care treatment for ROP, which is laser therapy. Your baby will be in this study for about 52 weeks after his/her birth. The study medication is given via an injection into the eye. The study will also involve blood draws, eye exams, and other physical exams for your baby. Study takes place at Oishei Children's Hospital.
This is a prospective, multicenter trial investigating the efficacy and safety of intravitreal aflibercept in type 1 Retinopathy of prematurity. ROP remains of of the leading causes of blindness in children, and the incidence is increasing due to increased neonatal survival. Infants identified with treatable ROP will be screened and, if qualified, be randomized to either alfibercept intravitreal injection or panretinal laser photocoagulation. This study conforms to national screening guidelines for identifying treatable ROP, and to national guidelines for instituting treatment. The follow-up care for the treated infants is also well within standard of care. After treatment, infants will be observed. If there is recurrence, 2 arms will be available, re-treatment with injection or laser, partially based on timing of recurrence and partially based on investigator experience. Primary endpoint is to establish superiority to laser, with a secondary endpoint for non-inferiority. Safety of intravitreal injection is also included in the study, although due to the nature of the patient population, a definitive answer on the safety of intravitreal injections is unlikely.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Children (newborn infants).
Gestational age at birth must be 32 weeks or less, birth weight must be 1500g or less
Must have retinopathy of prematurity (ROP) that has not yet been treated.
Must weigh at least 800 g
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