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

NCT07721298 | Completed

• 1 other identifier: 163/2021
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity (ROP)

Keywords

APROP; ROP; Ranibizumab; Aggressive posterior retinopathy of prematurity; Intra-vitreal Injection; Reactivation

Outcome Measures

Primary Outcomes (2)

• Disease regression following intravitreal ranibizumab

  Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease resolution or involution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.

  1 week after the initial intravitreal ranibizumab injection

• Disease regression following intravitreal ranibizumab

  Proportion of eyes demonstrating regression of aggressive posterior retinopathy of prematurity (AP-ROP), defined by disease involution \& resolution in the form of resolution of plus disease, reduction in vascular tortuosity and dilation, regression of extraretinal neovascularization, and continued peripheral retinal vascularization.

  1 week after the initial intravitreal ranibizumab injection

Secondary Outcomes (5)

• Disease Reactivation

  From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).

• Time to first reactivation

  Up to 72 weeks postmenstrual age.

• Number of intravitreal ranibizumab injections

  Up to 72 weeks postmenstrual age.

• Complete retinal Vascularization

  up to 72 weeks postmenstrual age

• Treatment-related complications

  From treatment until completion of follow-up (up to 72 weeks postmenstrual age).

Study Arms (1)

Intra-vitreal injection of Ranibizumab

EXPERIMENTAL

Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) received intravitreal ranibizumab (0.25 mg/0.025 mL) as the primary treatment. Eyes were followed with serial ophthalmic examinations and retinal imaging to evaluate disease regression, reactivation, retinal vascularization, anatomical outcomes, and treatment-related complications. Eyes demonstrating disease reactivation received repeat intravitreal ranibizumab according to the study protocol.

Drug: Intravitreal Ranibizumab injection

Interventions

Intravitreal Ranibizumab injection DRUG

Intravitreal ranibizumab (0.25 mg in 0.025 mL) was administered under sterile conditions using a 30-gauge needle through the pars plicata, 1.5 mm posterior to the corneal limbus. Repeat injections were performed in eyes with disease reactivation according to the study protocol.

Intra-vitreal injection of Ranibizumab

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ahmed Mansour, MD, PhD

  Ainshams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Single Arm Prospective non-randomized Interventional trial

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: September 10, 2021
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months following publication and ending 5 years after publication.
• Access Criteria: De-identified individual participant data will be available to qualified researchers upon reasonable request. Requests should include a methodologically sound research proposal and will be reviewed by the study investigators. Data will be provided after approval of the proposal and execution of a data sharing agreement, where applicable.

Locations

EG (1)