Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Eylea (Aflibercept, BAY86-5321); Laser photocoagulation
Intervention description: Solution in a sterile glass vial, Dose A, IVT injection.; Transpupillary conventional laser ablative therapy
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Maximum age: 32 Weeks
Healthy volunteers: No

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.
    

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