Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

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.