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

NCT07721298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-07-23

No results posted yet for this study

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)

Interventions

DRUG

Intravitreal Ranibizumab injection

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed Mansour, MD, PhD · Ainshams University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2024-09-01
Completion
2025-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721298 on ClinicalTrials.gov