Last updated on July 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Retinopathy of Prematurity
  • Age: - 100 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • Gestational age at birth 32 weeks or birth weight 1500 g
  • Patients with treatment-nave 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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