Phase 3
N=120
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Retinopathy of Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT04101721 ↗Enrolled (actual)
120
Serious AEs
36.7%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age — 77.8; 79.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- aflibercept (Drug); laser photocoagulation (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age |
77.8; 79.6 | — |
| SECONDARY Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age |
18.5; 15.1 | — |
| SECONDARY Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age |
29.6; 39.8 | — |
| SECONDARY Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
25.9; 18.3; 11.1; 6.5 | — |
| SECONDARY Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs |
51.9; 47.3; 7.4; 12.9 | — |
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.
Eligibility 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)
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.
Data sourced from ClinicalTrials.gov (NCT04101721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.