Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema (ERBDME)

17. Juni 2026 aktualisiert von: Ehab Mohamed Elsayed Mohamed Saad, Benha University

Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema: A Retrospective Observational Cohort Study

Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetes. Anti-VEGF agents are widely used to improve vision and reduce retinal swelling. However, treatment cost remains a major barrier in many healthcare systems.

This study evaluates the real-world effectiveness and safety of a ranibizumab biosimilar in patients with DME. Medical records of adult patients treated at a tertiary ophthalmology center will be reviewed. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) will be analyzed from baseline to final follow-up, along with treatment burden and safety outcomes.

The findings aim to provide evidence on visual and anatomical outcomes following biosimilar anti-VEGF therapy in routine clinical practice.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a retrospective observational cohort designed to evaluate the real-world effectiveness and safety of intravitreal ranibizumab biosimilar in patients with diabetic macular edema (DME). Medical records of adult patients diagnosed with type 1 or type 2 diabetes mellitus who received at least one injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026 will be reviewed. Eligible cases will include eyes with center-involving DME confirmed by optical coherence tomography (OCT) and a minimum follow-up period of 3-6 months. Baseline demographic, systemic, and ocular characteristics, including age, sex, diabetes duration, HbA1c level, lens status, prior ocular treatment, best-corrected visual acuity (BCVA), and central macular thickness (CMT), will be collected. Follow-up data will include changes in BCVA and CMT, number of injections received, and treatment regimen (loading dose, pro re nata, or treat-and-extend protocols). Outcomes will assess mean changes in BCVA and CMT from baseline to final follow-up, as well as the proportion of eyes achieving clinically meaningful visual and anatomical improvement. Safety outcomes will include ocular adverse events such as endophthalmitis, intraocular inflammation, retinal detachment, and intraocular pressure elevation, as well as systemic thromboembolic events. Statistical analysis will be performed using SPSS software, with appropriate parametric or non-parametric tests applied based on data distribution, and a p-value <0.05 considered statistically significant. The study will be conducted following Institutional Review Board approval and in accordance with the Declaration of Helsinki, with all data anonymized to ensure patient confidentiality.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

60

Kontakte und Standorte

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

Studienorte

  • Ägypten
    • Benha
      • Banhā, Benha, Ägypten, 13111
        • Benha 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
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026. Eligible eyes had a minimum follow-up duration of 3-6 months with available baseline and follow-up data for best-corrected visual acuity (BCVA) and central macular thickness (CMT). Patients with other causes of macular edema, prior recent anti-VEGF therapy within the washout period, significant media opacity affecting imaging, coexisting retinal pathology affecting vision, prior vitreoretinal surgery, or incomplete records were excluded. The population reflects a real-world retrospective cohort treated in routine clinical practice.

Beschreibung

Inclusion Criteria:

  • • Age ≥18 years

    • Diagnosis of type 1 or type 2 diabetes mellitus
    • Center-involving diabetic macular edema confirmed by OCT
    • Received at least one intravitreal ranibizumab biosimilar injection
    • Minimum follow-up duration of 3-6 months

Exclusion Criteria:

  • • Macular edema due to causes other than diabetes

    • Prior anti-VEGF treatment within specified washout period
    • Significant media opacity affecting imaging
    • Coexisting retinal pathology affecting vision (e.g., AMD, RVO)
    • Prior vitreoretinal surgery
    • Incomplete records or inadequate follow-up

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Ranibizumab biosimilar treatment group
This cohort includes adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar during the study period. All data are obtained retrospectively from medical records at the Retina Unit, Department of Ophthalmology, Benha University Hospitals. Patients were managed according to routine clinical practice using ranibizumab biosimilar administered via intravitreal injection, with treatment regimens including loading doses, pro re nata (PRN), or treat-and-extend (T&E) protocols as determined by the treating physician. No control or comparator group is included in this observational study. Outcomes of interest include changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), injection burden, and the incidence of ocular and systemic adverse events during follow-up.
Arzneimittel: Ranibizumab biosimilar
Intravitreal ranibizumab biosimilar administered as part of routine clinical care for the treatment of center-involving diabetic macular edema. Patients included in this retrospective cohort received at least one intravitreal injection of the biosimilar during the study period. Treatment regimens were determined by the treating physician and may have included an initial loading phase followed by pro re nata (PRN) or treat-and-extend (T&E) protocols based on disease activity assessed by clinical examination and optical coherence tomography (OCT). The intervention was not assigned by the investigators, and no randomization or experimental treatment allocation was performed.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in best-corrected visual acuity (BCVA)
Zeitfenster: Baseline to final follow-up (minimum 3-6 months)
Mean change in best-corrected visual acuity (BCVA) from baseline to the final follow-up visit after intravitreal ranibizumab biosimilar treatment in patients with diabetic macular edema. BCVA will be recorded in Snellen or converted to ETDRS equivalent letters where applicable, and compared between baseline and post-treatment measurements.
Baseline to final follow-up (minimum 3-6 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in central macular thickness (CMT)
Zeitfenster: Baseline to final follow-up (minimum 3-6 months)
Mean change in central macular thickness (CMT) measured by optical coherence tomography (OCT) from baseline to final follow-up after intravitreal ranibizumab biosimilar treatment in eyes with diabetic macular edema.
Baseline to final follow-up (minimum 3-6 months)

Mitarbeiter und Ermittler

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

Sponsor

Benha 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)

1. Januar 2022

Primärer Abschluss (Tatsächlich)

1. April 2026

Studienabschluss (Tatsächlich)

15. April 2026

Studienanmeldedaten

Zuerst eingereicht

17. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juni 2026

Zuerst gepostet (Tatsächlich)

23. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • DME-RANIBIZUMAB-BIOSIMILAR-202

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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 .

Klinische Studien zur Biosimilar

Klinische Studien zur Ranibizumab biosimilar

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Poland

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren