©2022 Stanford Medicine
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Recruiting
Trial ID: NCT04101721
Purpose
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
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.
Intervention(s):
drug: aflibercept
procedure: laser photocoagulation
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305