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

Phase 1

Conditions: MedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2019-001764-29-BE

Lead Sponsor: Regeneron Pharmaceuticals. Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 112

Inclusion Criteria

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 112
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP);Secondary Objective: -To assess the need for a second treatment modality<br>-To assess the recurrence of ROP in the study<br>-To assess the safety and tolerability of aflibercept;Primary end point(s): Proportion of patients with absence of active retinopathy of prematurity (ROP) and of unfavorable structural outcomes (For patients with both eyes enrolled in the study, both eyes must meet the endpoint);Timepoint(s) of evaluation of this end point: At Week 52 of chronological age

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Proportion of patients requiring intervention with a second treatment modality <br>2) Proportion of patients with recurrence of ROP <br>3) Proportion of patients with ocular treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) <br>4) Proportion of patients with systematic TEAEs and SAEs;Timepoint(s) of evaluation of this end point: 1,3,4: Baseline to Week 52 of chronological age<br>2: Through Week 52 of chronological age