Aflibercept bei Frühgeborenen-Retinopathie – intravitreale Injektion versus Lasertherapie Offene, randomisierte, zweiarmige, kontrollierte Studie um die Wirksamkeit, Sicherheit und Verträglichkeit des Medikaments Aflibercept (intravitreale (IVT) Injektion) im Vergleich zur Laserkoagulationsbehandlung bei Frühgeborenen mit Retinopathie (ROP) zu beurteilen

Drug: aflibercept
Procedure: laser photocoagulation

Key Inclusion Criteria: - Gestational age at birth =32 weeks or birth weight =1500 g - Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as: - Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or - Zone II Stage 2 plus or 3 plus, or - Aggressive posterior retinopathy of prematurity (AP-ROP) Key Exclusion Criteria: - Known or suspected chromosomal abnormality, genetic disorder, or syndrome - Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding - Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) - Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist - Presence of active ocular infection within 5 days of the first treatment - Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5) - ROP involving only Zone III NOTE: Other protocol defined inclusion/exclusion criteria apply.
Minimum age: N/A
Maximum age: N/A
Sex: All