Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Exclusion Criteria

• •Pediatric conditions rendering the infant ineligible to anti-VEGF treatment or to repeated blood draws as evaluated by a neonatal ICU specialist and a study ophthalmologist.
• •Congenital brain lesions significantly impairing optic nerve function.
• •Severe hydrocephalus with significantly increased intracranial pressure.
• •Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and 5).
• •ROP involving only the peripheral retina (i.e. peripheral zone II or zone III).
• •Known hypersensitivity to the study drug or to drugs with similar chemical structures.
• •Contraindications for an intravitreal injection as listed in ranibizumab SmPC.
• •Systemic use of anti-VEGF therapeutics.
• •Use of other investigational drugs - excluding vitamins and minerals - at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer.