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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    112
  • sponsor
    Regeneron Pharmaceuticals
Updated on 30 May 2021

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.

Details
Condition Retinopathy of Prematurity
Treatment Aflibercept, Laser photocoagulation
Clinical Study IdentifierNCT04101721
SponsorRegeneron Pharmaceuticals
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

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)

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
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