Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
