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Ocular Changes in Patients Using Tirzepatide or Semaglutide

3 novembre 2026 mis à jour par: Derya Budak Behrad, Istanbul University

Evaluation of Optic Nerve Head, Retinal Changes, and Choroidal Blood Flow in Patients With Diabetes and Obesity Using Tirzepatide or Semaglutide

This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.

Participants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods.

The study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This prospective observational cohort study will evaluate ocular structural and microvascular changes in adults with obesity receiving semaglutide or tirzepatide as part of routine clinical care. Participants will include individuals with and without type 2 diabetes mellitus.

The study population will be divided into four observational cohorts according to diabetes status and medication use:

  • Participants with obesity and type 2 diabetes receiving semaglutide.
  • Participants with obesity and type 2 diabetes receiving tirzepatide.
  • Participants with obesity without type 2 diabetes receiving semaglutide.
  • Participants with obesity without type 2 diabetes receiving tirzepatide.

Participants will undergo ophthalmologic examinations at baseline and during follow-up for up to 18 months. Assessments will include visual acuity, slit-lamp examination, intraocular pressure measurement, fundus examination, optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and enhanced depth imaging optical coherence tomography (EDI-OCT).

The study will evaluate changes in retinal nerve fiber layer thickness, retinal thickness, superficial and deep retinal vessel density, foveal avascular zone area, choriocapillaris flow deficit percentage, and choroidal thickness. Changes in visual acuity and intraocular pressure will also be assessed.

Ocular measurements obtained at baseline and during follow-up will be compared to investigate structural and microvascular changes associated with semaglutide or tirzepatide treatment. Differences between the observational cohorts may also be evaluated.

All medications will be prescribed by the treating physicians as part of routine clinical care. Treatment selection will not be determined by the study protocol, and no experimental ophthalmologic intervention will be performed.

Type d'étude

Observationnel

Inscription (Estimé)

40

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Turquie (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turquie (Türkiye), 34093
        • Recrutement
        • Istanbul University, Istanbul Faculty of Medicine
        • Contact:
        • Contact:
          • ADEM TELLIOGLU, MD
          • Numéro de téléphone: +90 5066107361

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care will be included. Participants will include individuals with and without type 2 diabetes mellitus. The study population will be evaluated in four observational cohorts according to diabetes status and medication: obesity with diabetes receiving semaglutide, obesity with diabetes receiving tirzepatide, obesity without diabetes receiving semaglutide, and obesity without diabetes receiving tirzepatide.

La description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of obesity
  • Receiving semaglutide or tirzepatide as part of routine clinical care
  • Participants with or without type 2 diabetes mellitus
  • Availability for baseline and follow-up ophthalmologic examinations

Exclusion Criteria:

  • Age under 18 years
  • Not receiving semaglutide or tirzepatide
  • Inability to complete the required ophthalmologic examinations or imaging assessments

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Obesity With Diabetes - Semaglutide

Participants with obesity and diabetes receiving semaglutide as part of routine clinical care.
Médicament: Semaglutide

Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity With Diabetes - Tirzepatide

Participants with obesity and diabetes receiving tirzepatide as part of routine clinical care
Médicament: Tirzepatide

Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity Without Diabetes - Semaglutide

Participants with obesity without diabetes receiving semaglutide as part of routine clinical care
Médicament: Semaglutide

Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.
Obesity Without Diabetes - Tirzepatide

Participants with obesity without diabetes receiving tirzepatide as part of routine clinical care
Médicament: Tirzepatide

Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Retinal Nerve Fiber Layer Thickness
Délai: Baseline to up to 18 months

Change in retinal nerve fiber layer thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
Baseline to up to 18 months
Change in Retinal Thickness
Délai: Baseline to up to 18 months

Change in retinal thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
Baseline to up to 18 months
Change in Superficial Retinal Vessel Density
Délai: Baseline to 18 months

Change in superficial retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months
Change in Deep Retinal Vessel Density
Délai: Baseline to 18 months

Change in deep retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months
Change in Foveal Avascular Zone Area
Délai: Baseline to 18 months

Change in foveal avascular zone (FAZ) area from baseline to follow-up, measured using optical coherence tomography angiography (OCT-A) and expressed in square millimeters (mm²).
Baseline to 18 months
Change in Choriocapillaris Flow Deficit Percentage
Délai: Baseline to 18 months

Change in choriocapillaris flow deficit percentage from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
Baseline to 18 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Visual Acuity
Délai: Baseline to up to 18 months

Change in visual acuity from baseline during follow-up
Baseline to up to 18 months
Change in Intraocular Pressure
Délai: Baseline to up to 18 months

Change in intraocular pressure from baseline during follow-up, measured in mmHg during routine ophthalmologic examination.
Baseline to up to 18 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Istanbul University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2026

Achèvement primaire (Estimé)

17 septembre 2027

Achèvement de l'étude (Estimé)

17 septembre 2027

Dates d'inscription aux études

Première soumission

28 octobre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

9 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025/2444

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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