Aflibercept for retinopathy of prematurity – intravitreal injection versus laser therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

1.Gestational age at birth = 32 weeks or birth weight = 1500 g
Type of Participant and Disease Characteristics
2.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 AP-ROP
3.Weight at baseline (day of treatment) = 800 g
4.Male or female
5.Signed informed consent from parent(s)/legally authorized representative(s) as described in Section 10.1.3 of the clinical trial protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical trial protocol

Are the trial subjects under 18? yes
Number of subjects for this age range: 135
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

Subjects are excluded from the study if any of the following per subject” criteria are met. A potential study eye is excluded from the study if any of the per eye” criteria are met:
Medical Conditions – per subject
1.Known or suspected chromosomal abnormality, genetic disorder or syndrome
2.Previous exposure to any IVT or systemic anti-VEGF agent, including maternal exposure during pregnancy and/or during breastfeeding
3.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)
4.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
5.Presence of active ocular infection within 5 days of the first treatment
Medical Conditions – per eye
6.Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
7.ROP involving only Zone III
8.Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint Prior/Concomitant Therapy – per subject
9.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
Prior/Concomitant Therapy – per eye
10.Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy) Prior/Concurrent Clinical Study Experience
11.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

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 in subjects diagnosed with retinopathy of prematurity (ROP) in comparison to laser;Secondary Objective: To assess the safety and tolerability of aflibercept<br>To assess the treatment burden of aflibercept and laser <br>To describe the systemic exposure to aflibercept<br>;Primary end point(s): Primary Endpoint<br>Proportion of patients with absence of active ROP and unfavorable structural outcomes at 24 weeks after starting study treatment<br><br><br>;Timepoint(s) of evaluation of this end point: at 24 weeks after starting study Treatment<br>

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: • From baseline to Week 24<br>;Secondary end point(s): Secondary Endpoints addressing primary objectives<br>Requirement for intervention with a second treatment modality from baseline to Week 24<br>Recurrence of ROP from baseline to Week 24<br>To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium<br><br>Secondary Endpoints addressing secondary objectives<br>•Number of aflibercept administrations from baseline to Week 24<br>•Number of laser treatments from baseline to Week 24<br>•Proportion of participants with ocular TEAEs and SAEs from baseline to Week 24 <br>•Proportion of participants with systemic TEAEs and SAEs from baseline to Week 24 <br>•Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling<br>•Presence of anti-drug antibodies before and 12 weeks after aflibercept injection<br>

Updated 3/30/2021

Aflibercept for retinopathy of prematurity – intravitreal injection versus laser therapy

Recruitment & Eligibility

Study & Design

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