Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

Inclusion Criteria:

• Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
• Subjects with treatment-naïve ROP classified according to the InternationalClassification 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)
• Weight at baseline (day of treatment) ≥ 800 g
• Signed informed consent from parent(s)/legally authorized representative(s), whichincludes compliance with the requirements and restrictions listed in the informedconsent form (ICF) and in this protocol.

Exclusion Criteria:

• Known or suspected chromosomal abnormality, genetic disorder or syndrome
• Previous exposure to any 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 3or higher, periventricular leukomalacia, congenital brain lesions significantlyimpairing optic nerve function, severe hydrocephalus with significantly increasedintracranial pressure)
• Pediatric conditions rendering the infant ineligible for study intervention atbaseline or for repeated blood draws as evaluated by a NICU specialist and a studyophthalmologist
• Presence of active ocular infection within 5 days of the first treatment
• Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and

• ROP involving only Zone III
• Ocular abnormalities that may interfere with the administration of study interventionor assessment of the study primary endpoint
• Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose ofprednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention
• Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablativelaser therapy, cryotherapy, and vitrectomy)
• Participation of the subject or the mother in other clinical trials requiringadministration of investigational treatments (other than vitamins and minerals) at thetime of screening, or within 30 days or 5 half-lives of administration of the previousstudy drug, whichever is longer