Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

Bayer113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

113

Conditions

Retinopathy of Prematurity (ROP)

Interventions

Eylea (Aflibercept, BAY86-5321)DRUG

Solution in a sterile glass vial, Dose A, IVT injection.

Laser photocoagulationPROCEDURE

Transpupillary conventional laser ablative therapy

Eligibility

Sex: ALLMax age: 32 Weeks

Medical Language ↔ Plain English

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

Locations (90)

Outcomes

Primary Outcomes

Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes

Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.

Time frame: At 24 weeks after starting study treatment

Secondary Outcomes

Proportion of Participants Requiring Intervention With a Second Treatment Modality

A second treatment modality for ROP was either rescue treatment or any other surgical or nonsurgical treatment for ROP (e.g. IVT anti-VEGF injection, ablative laser therapy, cryotherapy, or vitrectomy) captured as concomitant medication or surgery after study start.

Time frame: From baseline (treatment) up to week 24.

Proportion of Participants With Recurrence of ROP

Participants with recurrence of ROP were defined as subjects requiring re-treatment or rescue treatment after in the past the absence of treatment-requiring active ROP had been confirmed by the investigator.

Time frame: From baseline (treatment) up to week 24.

Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium

Eyes were evaluated for change in ROP activity scale proposed by the International Neonatal Consortium (2018). ROP Activity Scale value range is from 0 to 22. Value 0 to 7 are considered mild, 8 to 12 are moderate, and 13 to 22 are severe. Value 0 means the best and value 22 means the worst. Eyes evaluation was done at baseline and each visit.

Time frame: From baseline (treatment) up to week 24.

Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular TEAEs in treated eyes only were reported

Data from ClinicalTrials.gov

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