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.