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

18. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

**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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Cairo, Egypten
        • Ainshams University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease regression following intravitreal ranibizumab
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Reactivation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 72 weeks postmenstrual age
Proportion of eyes achieving complete peripheral retinal vascularization.
up to 72 weeks postmenstrual age
Treatment-related complications
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Efterforskere

  • Ledende efterforsker: Ahmed Mansour, MD, PhD, Ainshams University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. september 2021

Primær færdiggørelse (Faktiske)

1. september 2024

Studieafslutning (Faktiske)

1. februar 2025

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 163/2021

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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produkt fremstillet i og eksporteret fra U.S.A.

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Kliniske forsøg med Intravitreal Ranibizumab injection

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