Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy (FIREFLEYE)

Bayer

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Procedure: Laser photocoagulation; Drug: Eylea (Aflibercept, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04004208

20090

2018-002611-99 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

113 participants in 2 patient groups

Aflibercept arm

Experimental group

Description:

Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.

Treatment:

Drug: Eylea (Aflibercept, BAY86-5321)

Laser photocoagulation arm

Active Comparator group

Description:

Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.

Treatment:

Procedure: Laser photocoagulation