Status:
COMPLETED
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT04101721
Start Date
October 30 2019
End Date
August 18 2022
Last Update
July 20 2023
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Regeneron Study Site
Phoenix, Arizona, United States, 85016
2
Regeneron Study Site
La Jolla, California, United States, 92093
3
Regeneron Study Site
Loma Linda, California, United States, 92354
4
Regeneron Study Site
Orange, California, United States, 92868