Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity
Retina Disease, Retinopathy of Prematurity, Ranibizumab
About this trial
This is an interventional treatment trial for Retina Disease focused on measuring Aggressive ROP, Ranibizumab, Type 1 ROP, anti-VEGF, Laser photocoagulation
Eligibility Criteria
Inclusion Criteria: Infants with a birth weight of ≤ 1500 g or gestational age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Infants with type 1 ROP, as defined by the ETROP study 11, Zone 1, any stage ROP with plus disease; Zone 1, stage 3 ROP with or without plus disease; Zone 2, stage 2 or 3 ROP with plus disease( affecting either one or both eyes). Aggressive ROP (A-ROP), according to the International Classification of ROP (ICROP) criteria affecting either one or both eyes. Exclusion Criteria: Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or 5.
Sites / Locations
- Zagazig University, Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Aggressive ROP
Type 1 prethreshold ROP
Intravitreal injection (IVI) was performed under topical anesthesia in standard ophthalmic operating room. 5% povidone-iodine disinfection and topical antibiotic were instilled. Ranibizumab (0.25 mg/0.025 mL) was injected into the vitreous cavity with a 31-gauge needle, aiming the needle directly toward the optic nerve in direction of visual axis 1.0 mm posterior to the corneoscleral junction at the inferotemporal quadrant.
Intravitreal injection (IVI) was performed under topical anesthesia in standard ophthalmic operating room. 5% povidone-iodine disinfection and topical antibiotic were instilled. Ranibizumab (0.25 mg/0.025 mL) was injected into the vitreous cavity with a 31-gauge needle, aiming the needle directly toward the optic nerve in direction of visual axis 1.0 mm posterior to the corneoscleral junction at the inferotemporal quadrant.