Phase 3
Completed N=113
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
Retinopathy of Prematurity (ROP)
Source: ClinicalTrials.gov NCT04004208 ↗
Enrolled (actual)
113
Serious AEs
16.8%
Results posted
May 2022
Primary outcomePrimary: Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes — 0.855; 0.821 Proportion of participants
◆ Published Evidence
Highly cited
144citations · ~36 / year
Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial.
Summary
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Linked Publications (2)
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Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial.
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Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: results from the FIREFLEYE randomized phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes |
0.855; 0.821 | — |
| SECONDARY Proportion of Participants Requiring Intervention With a Second Treatment Modality |
0.072; 0.096 | — |
| SECONDARY Proportion of Participants With Recurrence of ROP |
0.161; 0.063 | — |
| SECONDARY Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium |
16.20; 15.63; -15.42; -14.77 | — |
| SECONDARY Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) |
38.7; 36.8 | — |
| SECONDARY Percentage of Participants With Ocular Serious Adverse Events (SAEs) |
13.3; 7.9 | — |
| SECONDARY Percentage of Participants With Systemic TEAEs |
52.0; 63.2 | — |
| SECONDARY Percentage of Participants With Systemic SAEs |
24.0; 36.8 | — |
| SECONDARY Concentrations of Free Aflibercept in Plasma |
480.607; 218.965; 133.093 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) |
0; 75; 1; 74 | — |
| SECONDARY Number of Participants With Potential Neutralizing Antibodies (NAb) |
— | — |
| SECONDARY Number of Aflibercept Administrations |
0; 34; 4; 0; 55; 3 | — |
| SECONDARY Number of Laser Treatments |
70; 0; 3; 4; 2; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
- Subjects with treatment-naïve 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)
- Weight at baseline (day of treatment) ≥ 800 g
- Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
- Known or suspected chromosomal abnormality, genetic disorder or syndrome
- Previous exposure to any 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 NICU 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 Stages 4 and 5)
- ROP involving only Zone III
- Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
- Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention
- Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
- Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
Data sourced from ClinicalTrials.gov (NCT04004208) and the linked publication. 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. Informational only — not medical advice.