Intravitreal Ranibizumab for Aggressive Posterior Retinopathy of Prematurity: A Prospective Interventional Case Series | NCT07721298

NCT07721298

Overview

NCT ID: NCT07721298
Lead Sponsor: Ain Shams UniversityOTHER
Official Title: Evaluation of Efficacy & Outcomes of Intra-vitreal Ranibizumab Injection in the Treatment of Aggressive Posterior Retinopathy of Prematurity
Brief Summary: Aggressive posterior retinopathy of prematurity (AP-ROP) is a severe form of retinopathy of prematurity that can progress rapidly and lead to retinal detachment and permanent vision loss if not treated promptly. Although laser photocoagulation has traditionally been the standard treatment, intravitreal anti-vascular endothelial growth factor (anti-VEGF) medications such as ranibizumab have emerged as an alternative treatment because they may preserve the developing peripheral retina.

This study was designed to evaluate the effectiveness and safety of intravitreal ranibizumab in premature infants with AP-ROP. The study assessed the initial response to treatment, the frequency and timing of disease reactivation, the need for additional injections, retinal vascularization during follow-up, and treatment-related complications.

The information obtained from this study is intended to improve understanding of the role of ranibizumab in the management of AP-ROP and to guide follow-up strategies for infants receiving anti-VEGF therapy.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) according to the International Classification of Retinopathy of Prematurity.

Gestational age ≤34 weeks or birth weight ≤2000 g.

Infants with gestational age >34 weeks or birth weight >2000 g were eligible if they had additional systemic risk factors, including respiratory distress syndrome, patent ductus arteriosus, sepsis, necrotizing enterocolitis, need for mechanical ventilation, or blood transfusion.

Infants whose parents or legal guardians provided written informed consent for treatment and follow-up.

Exclusion Criteria:

Previous treatment for retinopathy of prematurity with intravitreal anti-VEGF therapy, laser photocoagulation, cryotherapy, or vitreoretinal surgery.

Presence of retinal disease other than retinopathy of prematurity.

Major congenital ocular anomalies that could interfere with retinal assessment or treatment response.

Known genetic syndromes or systemic conditions judged by the investigators to significantly affect retinal vascular development or study follow-up.

Media opacity or other ocular condition preventing adequate fundus examination or retinal imaging.

Inability to complete the planned follow-up schedule.

Refusal or withdrawal of consent by parents or legal guardians.