Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

Official Title

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

Keywords

Retinopathy of Prematurity Retinal Diseases Premature Birth aflibercept laser photocoagulation

Eligibility

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.

Locations

  • Regeneron Study Site accepting new patients
    San Francisco California 94143 United States
  • Regeneron Study Site accepting new patients
    Palo Alto California 94303 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04101721
Phase
Phase 3
Study Type
Interventional
Last Updated