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

18 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

**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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

39

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
      • Cairo, Egitto
        • Ainshams University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease regression following intravitreal ranibizumab
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease Reactivation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: up to 72 weeks postmenstrual age
Proportion of eyes achieving complete peripheral retinal vascularization.
up to 72 weeks postmenstrual age
Treatment-related complications
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ain Shams University

Investigatori

  • Investigatore principale: Ahmed Mansour, MD, PhD, Ainshams University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2021

Completamento primario (Effettivo)

1 settembre 2024

Completamento dello studio (Effettivo)

1 febbraio 2025

Date di iscrizione allo studio

Primo inviato

18 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 163/2021

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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