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

18. Juli 2026 aktualisiert von: Ahmed Mansour , MD, PhD, Ain Shams University

Evaluation of Efficacy & Outcomes of Intra-vitreal Ranibizumab Injection in the Treatment of Aggressive Posterior Retinopathy of Prematurity

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

**Detailed Description**

Aggressive posterior retinopathy of prematurity (AP-ROP) is a rapidly progressive and vision-threatening subtype of retinopathy of prematurity (ROP) characterized by prominent plus disease, posterior retinal involvement, and rapid progression to retinal detachment if left untreated. Although laser photocoagulation has long been considered the standard treatment for severe ROP, its application in AP-ROP may be technically challenging because of the posterior location of the disease and is associated with permanent ablation of the peripheral retina, high myopia, and visual field constriction.

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as an alternative treatment that promotes rapid regression of retinal neovascularization while preserving peripheral retinal tissue. Ranibizumab is characterized by a shorter systemic and intravitreal half-life than other anti-VEGF agents, which may reduce systemic VEGF suppression but may also be associated with a higher risk of disease reactivation, necessitating prolonged surveillance after treatment.

This prospective interventional study was designed to evaluate the efficacy and safety of intravitreal ranibizumab as primary treatment for AP-ROP. The study aimed to assess the rate and timing of disease regression and reactivation, the need for additional intravitreal injections, retinal vascularization during follow-up, and anatomical outcomes. The study also sought to characterize the morphological patterns of disease reactivation and evaluate treatment-related ocular and systemic complications.

The findings are intended to contribute to the growing body of evidence regarding anti-VEGF therapy for AP-ROP and to provide additional data on long-term disease behavior following ranibizumab treatment in premature infants.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

39

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ägypten
      • Cairo, Ägypten
        • Ainshams University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intra-vitreal injection of Ranibizumab
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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disease regression following intravitreal ranibizumab
Zeitfenster: 1 week after the initial intravitreal ranibizumab injection
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
Zeitfenster: 1 week after the initial intravitreal ranibizumab injection
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disease Reactivation
Zeitfenster: From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).
Incidence of AP-ROP reactivation requiring retreatment following initial disease regression
From the initial injection until completion of follow-up (up to 72 weeks postmenstrual age).
Time to first reactivation
Zeitfenster: Up to 72 weeks postmenstrual age.
Postmenstrual age (PMA) at the first episode of disease reactivation requiring retreatment.
Up to 72 weeks postmenstrual age.
Number of intravitreal ranibizumab injections
Zeitfenster: Up to 72 weeks postmenstrual age.
Number of intravitreal ranibizumab injections required per eye during the study period.
Up to 72 weeks postmenstrual age.
Complete retinal Vascularization
Zeitfenster: up to 72 weeks postmenstrual age
Proportion of eyes achieving complete peripheral retinal vascularization.
up to 72 weeks postmenstrual age
Treatment-related complications
Zeitfenster: From treatment until completion of follow-up (up to 72 weeks postmenstrual age).
Incidence of ocular or systemic complications associated with intravitreal ranibizumab treatment.
From treatment until completion of follow-up (up to 72 weeks postmenstrual age).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ain Shams University

Ermittler

  • Hauptermittler: Ahmed Mansour, MD, PhD, Ainshams University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. September 2021

Primärer Abschluss (Tatsächlich)

1. September 2024

Studienabschluss (Tatsächlich)

1. Februar 2025

Studienanmeldedaten

Zuerst eingereicht

18. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 163/2021

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in this study, including demographic characteristics, baseline clinical variables, treatment data, follow-up assessments, and outcome measures, will be made available.

IPD-Sharing-Zeitrahmen

Beginning 6 months following publication and ending 5 years after publication.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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